AI · SaaS
Boca Raton, Florida Thursday Oct 22, 2026 @ 5:00 AM Eastern —
AgeReverse, a Canadian longevity company focused on healthy aging and cellular vitality, today announced that its flagship RESURGE formulation is now available to U.S. consumers through OneLavi.com, marking another milestone in the company's expanding U.S. retail presence.
The One Lavi launch follows the recent availability of RESURGE on Amazon and reflects AgeReverse's strategy to build a broader U.S. distribution network through multiple retail and e-commerce channels.
"Expanding our availability through OneLavi is another important step in introducing AgeReverse to more consumers across the United States," said Kubi Turkmen, Founder and CEO of AgeReverse. "Our goal is to make RESURGE accessible through established retail destinations while continuing to build awareness of our comprehensive approach to healthy aging."
AgeReverse developed RESURGE around the scientific framework of the 12 Hallmarks of Aging, which describes interconnected biological processes associated with aging. Rather than emphasizing a single ingredient or isolated wellness benefit, the company designed its flagship formulation to bring together multiple ingredients in a simplified daily regimen.
The 90-capsule RESURGE formulation includes NMN, Resveratrol, Quercetin, Fisetin, CoQ10, Astragalus Extract, Hyaluronic Acid, Aronia Extract and Noni Berry.
Key features of RESURGE include:
Developed around the scientific concept of the 12 Hallmarks of Aging
Combines multiple ingredients associated with antioxidant support and everyday wellness
Supports nutrient metabolism, cardiovascular health and immune function
Helps support collagen formation, connective tissue development and joint health
Simplifies what the company describes as 12 or more individual products and 15 or more capsules per day into a three-capsule daily regimen
Manufactured in GMP-certified facilities in Ontario, Canada using vegan capsules
Registered as a Natural Health Product with Health Canada under NPN 80130202
The expansion onto OneLavi comes as AgeReverse continues developing its presence in the U.S. longevity and healthy aging market. The company recently participated in the ECRM Vitamin, Weight Management & Sports Nutrition Session in Palm Beach Gardens, Florida, where it introduced RESURGE and its broader product strategy during scheduled meetings with retail buyers across health, specialty, food, drug and mass retail channels.
Beyond RESURGE, AgeReverse is developing a range of products focused on both internal wellness and external skin aging. Its broader plans include biological age testing, daily skincare, professional aesthetic formulations and non-invasive mesotherapy technology.
"Our long-term strategy is about more than a single product or sales channel," Turkmen added. "We are building a complete range of healthy aging solutions while expanding the ways consumers can access the AgeReverse brand."
The OneLavi availability represents another step in that strategy, complementing the company's existing Amazon presence and its ongoing efforts to develop additional U.S. retail relationships.
RESURGE is now available on OneLavi.com and Amazon.
Visit the AgeReverse Website and follow the company on Instagram and LinkedIn.
About AgeReverse
AgeReverse is a Canada-based longevity wellness company focused on developing science-driven products designed to support healthy aging and cellular vitality. Founded by Kubi Turkmen, who has more than 30 years of experience in anti-aging innovation, the company’s approach combines longevity research, telomere science, and wellness innovation to create comprehensive healthy aging solutions. The company’s expanding AgeReverse platform includes longevity supplements and other wellness technologies designed to support multiple biological pathways associated with aging and long-term vitality. Products are manufactured in GMP-certified facilities in Ontario, Canada. Learn more at the company’s website.
FDA Disclaimer
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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Media · Internet & apps
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Oct 22 · 02:16·MarketersMEDIA
AI · SaaS
GitLab is not affected by PHP2Shell (CVE-2026-109618 and CVE-2026-109619). The GitLab application is not written in PHP and does not run it to serve web requests, and our Security team has found no evidence of impact to GitLab-managed infrastructure. GitLab.com, GitLab Self-Managed, and GitLab Dedicated are not impacted.
PHP is a widely used programming language that runs on web servers and powers popular platforms like WordPress, Drupal, and Magento, so a flaw in PHP itself can affect many websites and applications. On October 21, 2026, the PHP project fixed two critical remote code execution flaws in PHP, together known as PHP2Shell (CVE-2026-109618 and CVE-2026-109619). PHP rates both 9.2 on CVSS v4.0. The flaws are in the PHP engine, not in any framework, library, or application code, so there is no application-level fix. Any web server that runs PHP is affected, including NGINX and Apache. The PHP project confirmed the vulnerability on Apache with mod_php, where an unauthenticated request can achieve remote code execution before any application code runs.
Upgrade every server and container that runs PHP to serve web requests to PHP 8.5.12, 8.4.27, 8.3.36, or 8.2.35, or to your distribution’s patched package now.
This guide is for security and platform teams with PHP projects on GitLab. It covers the fixed version for each PHP branch and distribution, how to use GitLab features to locate PHP projects across your groups, how to track remediation, and how to check for signs of compromise.
Upgrade PHP to a fixed version now
Upgrade the PHP runtime on every host and in every container image to a fixed version. Framework updates, Composer updates, input validation, and authentication don’t help, because PHP handles the request before application code runs.
BranchFixed in
PHP 8.5.x8.5.12
PHP 8.4.x8.4.27
PHP 8.3.x8.3.36
PHP 8.2.x8.2.35 (end of life December 31, 2026)
PHP 8.6 release candidates8.6.0RC4. The official php:8.6-rc image was still on RC3 on October 21, and RC3 does not have the fix.
PHP 8.1 and olderNo official release. PHP published minimal source backports for 7.4, 8.0, and 8.1, and some distributions ship patched packages.
If your PHP comes from a distribution package, upgrade that package. Fixed package versions as of October 22:
DistributionFixed package
Ubuntu 26.04php8.5 8.5.4-0ubuntu1.5
Ubuntu 24.04php8.3 8.3.6-0ubuntu0.24.04.13
Ubuntu 22.04php8.1 8.1.2-1ubuntu2.28
Debian 13php8.4 8.4.27-1~deb13u1
Debian 12php8.2 8.2.35-1~deb12u1
Alpine 3.24php83 8.3.36, php84 8.4.27, php85 8.5.12
RHEL 10php 8.3.36-1.el10_2 (RHSA-2026:87070), php8.4 8.4.27-1.el10_2 (RHSA-2026:87071)
RHEL 9php 8.0.30-8.el9_8.1 (RHSA-2026:87151), php:8.2 8.2.35-1 (RHSA-2026:87072), php:8.3 8.3.36-1 (RHSA-2026:87079); php:8.4 had no fix yet on October 22
RHEL 8php:7.4 7.4.33-8 (RHSA-2026:87080); check Red Hat’s CVE pages for php:8.2. Retired streams (7.2, 7.3, 8.0) get no fix
Sources: Ubuntu, Debian, Alpine, and Red Hat security trackers, as of October 22, 2026.
Ubuntu, and Red Hat for its 7.4 and 8.0 packages, keep the old upstream version number and backport the fix. Compare the package versions rather than php -v. Restart every process that runs PHP after upgrading.
Rebuild your container images. If your image uses a floating tag of the official php image, such as php:8, php:8.3, php:8.3-apache or php:latest, rebuild it with docker build --pull and redeploy it. Images that pin a patch version, such as php:8.3.35-apache, need the tag changed to the fixed version first. Images built on derivatives such as wordpress or drupal get the fix only after their maintainers publish an updated image, so check the upstream image before you rebuild.
Locate PHP projects across your GitLab groups
Any project that runs PHP to serve web requests needs a fixed version, including the ones that are easy to forget, such as an internal dashboard, a marketing site, or a CI job image. Finding them takes two views: a static search of what your repositories declare and your images contain, and a runtime inventory of what actually runs. GitLab covers the static view with two features. Use both, in this order.
1. Container scanning
Container scanning reports vulnerabilities in operating system packages, so it finds PHP installed with apt, apk, or dnf, and it reports the two CVEs once they reach the scanner’s vulnerability database. To turn it on for a project, add the template to .gitlab-ci.yml:
include:
- template: Security/Container-Scanning.gitlab-ci.yml
You can also use a group-level scan execution policy to turn container scanning on for every project in a group at once. When a policy is enabled, the next time a pipeline is run, it will be run with container scanning. Container scanning results for the default branch can be reviewed in the Vulnerability Report after the scanner completes.
Additionally, you can set up Merge Request Approval policies with container scanning. With merge request approvals in play, if a code change contains PHP2Shell, the policy will block a merge without approval from the selected parties.
Container scanning detects only PHP installed as a package. PHP compiled from source, including the official php images, has no package record, so a project can pass container scanning and still run a vulnerable PHP. Code search covers that gap.
2. Code search
Exact code search can find the two types of files that indicate a PHP project. Run these at the top-level group with regular expression mode enabled (the .* toggle at the right of the search box):
Container base images: This query searches for every file GitLab detects as a Dockerfile. The pattern matches any image whose name or tag contains php, so it also finds derivatives such as wordpress, frankenphp, or bitnami/php-fpm. Expect a few false positives that you can rule out by reading the result: lang:Dockerfile ^FROM.*php
Composer projects: This query finds projects that use PHP even when they have no Dockerfile, or when the Dockerfile takes its image from a build argument such as FROM $BASE_IMAGE:
file:composer\.json$
Exact code search covers the default branch only. On GitLab.com it is on by default for paid plans. On GitLab Self-Managed instances an administrator must install Zoekt first. GitLab Dedicated doesn’t support exact code search.
For each result, confirm the version. You can check the FROM php:<tag> line, or run php -v in the running container, and compare it with the table above. The group dependency list shows Composer packages and framework versions but not the PHP runtime version.
3. Compare with your runtime inventory
Container scanning and code search show what your projects declare and build, not what runs. PHP can run outside your GitLab projects, for example on web servers with mod_php or PHP-FPM enabled only in their configuration, on hosts configured by hand, or in containers that still run in clusters without an active pipeline. Compare the static results with an inventory of your running workloads from your configuration management (Ansible, Puppet, Chef, etc.), cloud, or VM inventory tools. For Kubernetes, operational container scanning scans the images that run in your clusters, with the same package-only detection as container scanning. Treat every PHP runtime that appears in only one of the two views as a gap to investigate.
Remediate at scale with GitLab Duo Agent Platform
Start with asking GitLab Duo Agentic Chat to:
collect every container scanning finding for CVE-2026-109618 and CVE-2026-109619 across the group from the vulnerability report (requires an Ultimate subscription)
run the code search queries above across the group, review each hit and read the PHP version from the Dockerfile or the Composer files
open a merge request per affected project that bumps the base image tag or the package to the fixed version, and assign it to the right maintainer
track the whole effort in an epic with one issue per project, and is closed when the fixed version is deployed and confirmed
From each issue, the Developer Flow can open a merge request that updates the base image tag or package to a fixed version. Turn on automatic reviews with the Code Review Flow to get a first review that follows your custom review instructions. Review and merge each merge request, then close the issue once the fixed version is deployed.
Searches find candidates, but a security or platform engineer still has to review each match, resolve CI includes, and tell what the code declares apart from what actually runs. An example agent skill from the GitLab Developer Advocacy team handles this work. It runs on GitLab Duo Agent Platform and with agents that use GitLab MCP server or the glab CLI, such as Claude Code, Codex, and Cursor.
The skill checks container images, CI jobs, OS packages, configuration management variables, Composer pins, and environments. It returns a cited findings table with deployment evidence, and open gaps. The skill is read-only: It makes no changes, and remediation merge requests remain a separate, reviewed step. It cannot confirm what is running on hosts it cannot access, so verify those directly. Adapt the skill to your own environment before you use it.
Check for compromise
Reports of exploitation differ. Security researchers reported an exploit attempt on October 17, 2026, before public disclosure, and further reports of exploitation followed the release. The PHP project identified no functional exploits at the time of release. If an internet-facing server ran a vulnerable PHP version, review its logs from October 17, 2026, onward for:
Multipart requests followed by memory-limit errors or repeated HTTP 500 responses
Unusually large or malformed PHPSESSID response cookies
Unexplained PHP worker restarts, or shell processes started by PHP workers
Unexpected files on the PHP web server, outbound connections from PHP workers, or unexpected cron entries
A successful exploit can return HTTP 200 and leave the worker running, so an absence of errors doesn’t rule out compromise. If you find signs of exploitation, isolate the server and start an incident investigation. Where possible, capture memory, disk, and logs before patching and restarting. Restarting PHP workers may erase evidence. CVE-2026-109619 can also expose process memory, even when an attacker doesn’t achieve code execution. Rotate any credentials, tokens, or keys the PHP process could read.
Note: Scanners may flag the Gemnasium dependency scanning image (gemnasium:6), deprecated since GitLab 17.9, for its bundled PHP. It is used only as a command-line tool and never handles HTTP requests, so it is not exploitable, and a fixed version has already shipped under the same tag.
Timeline
DateWhat happened
August 1Calif discovers the first flaw during an AI-assisted PHP audit and reports it to PHP on August 11; Wiz Research independently finds and reports the flaws on August 24.
October 17Amazon’s honeypots record the first known exploit attempt, while the flaws are still under embargo.
October 20PHP announces that a security release fixing two critical vulnerabilities will ship on October 21.
October 20Vulnerability details leak before coordinated disclosure. (Huntress)
October 21, 14:00 UTCPHP releases 8.5.12, 8.4.27, 8.3.36 and 8.2.35 and publishes the advisories.
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Oct 22 · 00:00·GitLab
Finance · Healthcare
Mountain View, CA, 21 Oct, 2026 - Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.
Unicycive Therapeutics, Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/unicycive-therapeutics.
"We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "This resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor's facility was last inspected by the FDA in March 2024 and received 'No Action Indicated' status. We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia."
The Company does not know whether the FDA will decide to conduct a pre-approval inspection of the new third-party DP vendor. Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice (cGMP), the Company plans to seek FDA alignment on a shorter approval timeline.
The Company resubmitted the NDA following the second CRL, which cited deficiencies previously identified at the original third-party manufacturer of the drug product, which the FDA had not been able to re-inspect during the prior submission review.
The timing and outcome of any FDA inspection of the original third-party vendor will be determined solely by the FDA.
The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, as well as CMC data. The FDA did not raise any concerns regarding OLC's preclinical or clinical data, including safety data, included in the original NDA submission.
About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.[1] Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
[1] Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; Unicycive's clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; Unicycive's dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of its NDA; the risk that the inspection of the original or new third-party manufacturing vendor may not occur within a timeframe that benefits its regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm its financial condition and increase its costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of its products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner, LifeSci Advisors, kgardner@lifesciadvisors.com
Media Contact:
Unicycive Therapeutics, media@unicycive.com
Additional Contact:
David Shapiro, B2i Digital, Inc., +1 212-579-4844, david@b2idigital.com
B2i Digital Social Media:
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To learn more about the B2i Digital Media Network, visit: https://b2idigital.com/media-network
SOURCE: Unicycive Therapeutics, Inc.
Oct 22 · 00:00·ACN Newswire
Internet & apps
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Oct 20 · 16:11·MarketersMEDIA
Healthcare · Automotive
FDA approval is based on results from the landmark phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone1
First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care
Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years2,3
Approval marks the twelfth indication for Tecentriq in the US
Basel, 9 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumour characterised by high mutation rates. This approval marks the twelfth indication for Tecentriq in the US.
“This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.”
“Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator for the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death.”
The FDA approval is based on the landmark phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA® MMR RxDx Panel.1 The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6.1
Colon cancer remains one of the world's most common and deadliest tumours.4 Over one million people are diagnosed globally each year, and nearly 25% of all colon cancers are diagnosed at stage III.2-4 Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years.2,3 Approximately 15% of colon cancer patients present with dMMR or microsatellite instability-high (MSI-H) tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.5
Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this immunotherapy-based adjuvant option to patients with dMMR colon cancer worldwide as soon as possible.
About the ATOMIC study
ATOMIC (A021502, NCT02912559) is a phase III, randomised, open-label, multicentre study investigating the addition of Tecentriq® (atezolizumab) to modified (m)FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomised 1:1 to receive either mFOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or mFOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS).
The global study in the US was sponsored by the US National Cancer Institute (NCI), part of the National Institutes of Health, and led by the Alliance for Clinical Trials in Oncology (Alliance) with participation from other NCI-funded National Clinical Trials Network (NCTN) groups. Genentech, a member of the Roche Group, provided support for the study through a Cooperative Research and Development Agreement between NCI and Genentech. The trial was led globally by Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator within the Alliance. German participation in this major international academic collaboration was enabled through close cooperation between the Alliance and the AIO-Studien-gGmbH, in partnership with the AIO (Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society (Deutsche Krebsgesellschaft, DKG), under the national leadership of Prof. Dr. Anke Reinacher-Schick (Ruhr-Universität Bochum). AIO-affiliated study sites enrolled patients during the later recruitment phase, ensuring access for eligible patients in Germany.
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.
About Roche in oncology
For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Sinicrope F, et al. Atezolizumab plus FOLFOX for Stage III Mismatch Repair–Deficient Colon Cancer. N Engl J Med. 2026;394:1155-1166.
[2] Gonzalez B, et al. Analyzing recurrence in colorectal cancer: Is a five years follow-up enough? Annals of Oncology. 2024;35(1);11.
[3] Nors J et al. Incidence of Recurrence and Time to Recurrence in Stage I to III Colorectal Cancer: A Nationwide Danish Cohort Study. JAMA Oncology. 2024;10(1):54–62.
[4] World Health Organization. Cancer [Internet; cited 2026 October]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.
[5] Boland CR, et al. Microsatellite Instability in Colorectal Cancer. Gastroenterology. 2010;138:2073–2087.
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
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Irène Stephan
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Phone: +41 79 775 66 12
Roche Investor Relations
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Attachment
Media&Investor Release FDA approval for Tecentriq Tecentriq Hybreza English
Oct 9 · 05:00·Roche
Crypto · AI
Every software build is assembled from open source packages, base images, and libraries, with your code on top. When one of those components is missing or has drifted, the build fails. At agent speed, those failures multiply, and no team can clear them as manual exceptions.
Project-by-project registry sprawl makes it worse because retention rules, storage limits, and publish access all live separately inside each project. Project-level design works when a person sets up each registry by hand, but breaks down when agents are running continuously across hundreds of projects.
At GitLab Transcend today, we announced GitLab Artifact Central: one organization-level registry that replaces hundreds of project-level ones, so every pull or publish by a human or an agent runs through the same governed door, enabling platform teams to assemble the right software the first time.
Here is more on why we developed Artifact Central, and how it can help your team.
Set policy once, enforce everywhere
In GitLab, retention rules, storage limits, and who can publish all live inside each project’s free package and container registry, configured on its own. GitLab Artifact Central moves that job up one level. Teams assign retention rules, quota settings, and access policies once at the organization level, instead of recreating them in every project underneath it.
Every repository is closed by default: Being a member of the organization is the gate, not the grant. Organization membership alone doesn't unlock a single repository until a role grants it. We’ve built four roles specifically for artifacts: Admin, Manager, Contributor, and Viewer. These roles are kept separate from GitLab's existing project roles, so granting someone access to a repository never touches their privileges anywhere else.
One URL for publishing, proxying, or both
Instead of navigating an internal wiki page explaining what is where, developers point to one URL for everything. GitLab Artifact Central does this through three repository types:
Hosted — The private packages and images your teams build and publish.
Remote — A proxy in front of an external source, like Docker Hub or Maven Central, with the connection tested before anything depends on it.
Virtual — A single endpoint that brings hosted and remote repositories together. GitLab checks the hosted repository first, then falls back to the remote source. The first external pull is cached, so subsequent pulls come directly from GitLab without another trip to the internet.
Virtual repositories matter most for teams comparing GitLab with other artifact management solutions. They give developers the familiar single-endpoint experience without requiring them to think about where an artifact lives. Whether it was built internally or pulled from an external registry, developers request it the same way. During the beta period, Artifact Central supports Maven, npm, Docker, and OCI, with more formats to follow.
Trace anything back, automatically
Here's the part that's hard to replicate outside GitLab. Every artifact that publishes through GitLab Artifact Central carries its build provenance automatically: which pipeline built it, which branch and commit it came from, who triggered the job. Since it is the same platform that ran the build, the registry already knows.
Authentication works the same way. Publishing and pulling use CI_JOB_TOKEN, the identity your pipelines already have, for people and agents alike. An agent publishing or pulling through CI pipelines uses that exact same job token, not a bolted-on service account with separate permissions to maintain. With a standalone registry, tracing an artifact back to its source means separately correlating IDs across your CI system and your registry – using a script someone owns and maintains. With Artifact Central, the pipeline, branch, commit, and job are already attached to the artifact itself.
Answer 'what did we publish?' in seconds
Artifact Central lives in the same platform as your code, merge requests, and pipelines, so artifacts published from CI carry their build provenance: the pipeline that built them, the commit, and who published them.
Next, we plan to connect that across your organization through GitLab Orbit, so "which of my running services are affected by this vulnerability?" becomes one question with one answer, instead of a manual search across four or five tools.
Pair Artifact Central with Dependency Firewall
GitLab Dependency Firewall, a separate GitLab product now in early access for Premium and Ultimate customers, works out of the box with Artifact Central. With Dependency Firewall, you can stop risky packages before they ever reach a build. You add its check to each pipeline using the glab CLI, so coverage is pipeline by pipeline, no matter which package manager your teams use. Next, we plan to enable tighter integration between the two capabilities, so that one policy for your whole organization blocks risky packages by vulnerability, license, or package age the moment they're pulled.
Two benefits of the same registry
Here's what that looks like from two different desks: a developer shipping code, and the platform team making sure the whole thing holds together.
A developer publishing from CI. Your pipeline publishes a Maven artifact using the job token it already has without any new secrets to manage. If that same developer needs an internal package alongside something from Maven Central, they point at one virtual repo URL and let GitLab Artifact Central sort out where each one actually lives.
A platform team setting policy once. Instead of configuring rules across 100s of separate projects, an admin sets storage quotas and repository access rules at the organization level, one time — and every repository underneath inherits it. When someone asks how much the company is storing, and where, there's one dashboard with the answer.
Migrating your artifacts
Most companies aren't starting from zero, and switching cold from an existing registry isn't realistic. With GitLab Artifact Central, you can add your existing repos as remotes behind a virtual repo, so developers point at one URL and artifacts move over only when a build actually asks for one. There is no need for bulk copies, weekend migration windows, or moving petabytes of data across your network.
Your old registry remains the system of record. When you're ready, you convert that remote to a hosted repo on Artifact Central. Your migration is safer and gradual.
Try Artifact Central, free in beta
GitLab Artifact Central is available today in beta for GitLab.com, with availability on GitLab Self-Managed planned for later this month. There's no billing during the beta, and nothing to purchase. We're tracking usage to shape pricing ahead of general availability, and we'll share details then.
Help us continue to build GitLab Artifact Central
None of this would be where it is without our design partners, who've been running Artifact Central with real workflows for weeks. Their feedback already shaped what's shipping today, and your feedback will shape what comes next.
No invitation is required to participate in the beta of Artifact Central, just sign up on our website and a member of our team will be in touch to help enable it for your account. If you don’t have a GitLab account yet, you can also sign up for the beta, and a member of our team will reach out.
We can't wait to see what you build.
Watch the replay of our Transcend event to see demos of new platform capabilities and explore what it takes to carry the speed of agentic AI across the full software lifecycle.
Oct 6 · 00:00·GitLab
AI · Healthcare
New real-world results for Vabysmo in nAMD, DME and RVO reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals1-3
Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care4,5
With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide1-3
Basel, 1 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo® (faricimab) in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).1-3 Across all study cohorts, results confirm the real-world effectiveness of Vabysmo in line with Phase III trial results, with vision gains and robust anatomical improvements in untreated eyes and stable or improved vision with improved anatomical outcomes in previously treated eyes.1-3
In the nAMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment.1,2 In RVO, both subtypes of the disease showed improvements in efficacy in people treated with Vabysmo.3 In the central/hemi-RVO cohort, vision and CST improved in both previously untreated and treated eyes after six months of Vabysmo therapy.3 In the branch RVO cohort, vision and CST improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after six months of Vabysmo treatment.3 The data are being presented at the EURETINA 2026 Annual Meeting in Vienna, Austria.
“These real-world results underscore how the efficacy and safety observed in our pivotal Vabysmo studies translate directly into routine clinical practice globally,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The sustained visual improvements and meaningful anatomical drying seen in the VOYAGER study reinforce the role of Vabysmo in helping to address important unmet needs for patients with retinal conditions.”
“In daily clinical practice, we manage diverse patient populations with complex treatment histories who don’t always mirror the strict entry criteria of controlled Phase III trials.” said Professor Robyn Guymer, Chair of the VOYAGER Steering Committee and Deputy Director of the Centre for Eye Research Australia. “The latest VOYAGER data give physicians from across the world the confidence that Vabysmo delivers sustained visual gains, meaningful anatomical drying, and an established safety profile in everyday practice – whether a patient is starting treatment for the first time or transitioning from another therapy.”
The new VOYAGER real-world data in nAMD, DME and RVO are consistent with previous Phase III study results and demonstrate the effectiveness, durability and safety of Vabysmo across diverse global practices.1-3 Across all cohorts of the study, the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) was consistently reduced in previously untreated and treated eyes.1-3 In the nAMD and DME groups, fewer Vabysmo injections were received during months 7-12 compared with months 1-6, suggesting extension of treatment intervals.1,2
Mean change in visual acuity (VA)
Early Treatment Diabetic Retinopathy Study (ETDRS) lettersMean change in central subfield thickness (CST)
µmPresence of subretinal fluid (SRF)
% of eyesPresence of intraretinal fluid (IRF)
% of eyes
nAMD (after 12 months of Vabysmo treatment)1
No prior treatment+4.6–110.572.1→25.348.5→20.6
Previously treated-0.1-26.161.6→37.935.4→25.0
DME (after 12 months of Vabysmo treatment)2
No prior treatment+8.2-127.826.5→6.887.3→58.1
Previously treated+2.7-71.322.1→9.380.5→68.1
Branch RVO (after 6 months of Vabysmo treatment)3
No prior treatment+10.0-171.336.3→11.883.8→50.0
Previously treated+2.0-59.015.9→6.682.6→80.3
Central/hemi-RVO (after 6 months of Vabysmo treatment)3
No prior treatment+16.6-287.450.7→9.885.7→29.4
Previously treated+3.9-63.414.9→10.389.4→74.4
In VOYAGER, the Vabysmo safety profile was generally consistent with that established in the Phase III studies in nAMD, DME and RVO.1-3
About VOYAGER
VOYAGER is the largest global, prospective, non-interventional real-world study of Vabysmo (faricimab).1-3 It captures real-world data from 28 countries/regions across six continents representing more than 5,000 patients treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) or retinal vein occlusion (RVO).1-3 The study leverages state-of-the-art AI and deep learning algorithms to evaluate SD-OCT images captured during routine clinical practice.4-6
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.7-9 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.9,10 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO).7,8,11-14 Review by other health authorities is ongoing.
About Roche in Ophthalmology
At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care.
Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Guymer R, et al. One-year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With nAMD From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[2] Sheth V, et al. One–Year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With DME From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[3] Hattenbach L-O, et al. Real-World Clinical and Anatomical Outcomes With Faricimab in Patients With Retinal Vein Occlusion From a Global, Prospective Observational Study: The VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[4] Bailey C, et al. Anatomical Outcomes of Faricimab in Patients with Neovascular Age-Related Macular Degeneration: 12-Month Real-World Imaging from the VOYAGER Study. Presented at:26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[5] Koh A, et al. Anatomical Outcomes of Faricimab in Patients with Diabetic Macular Edema: 12-Month Real-World Imaging from the VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[6] Guymer R, Bailey C, Chaikitmongkol V, et al. Rationale and Design of VOYAGER: Long-term Outcomes of Faricimab and Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Clinical Practice. Ophthalmol Sci. 2024;4(3):100442. doi:10.1016/j.xops.2023.100442.
[7] United States (US) Food and Drug Administration (FDA). Highlights of Prescribing Information, Vabysmo. April 2026. [Internet; cited September 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761235s008lbl.pdf
[8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. May 17, 2022. [Internet; cited September 2026]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative
[9] Heier JS, Khanani AM, Quezada Ruiz C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1.
[10] Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6.
[11] European Medicines Agency. Summary of Product Characteristics, Vabysmo. August 2026. [Internet; cited September 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[12] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[13] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[14] Roche data on file.
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
Phone: +41 79 961 92 50
Irène Stephan
Phone: +41 79 377 83 75Albert Thottiyil
Phone: +41 79 775 66 12
Attachment
Media Release Vabysmo EURETINA 2026 English
Oct 1 · 06:00·Roche