273 press releases in English indexed under government & policy.
AbbVie presents 60 abstracts and presentations from a robust portfolio spanning across alopecia areata, atopic dermatitis, hidradenitis suppurativa,...
RINVOQ is now approved in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of...
AbbVie (NYSE: ABBV) today presented new VRAYLAR® (cariprazine) data at Psych Congress 2026 in New Orleans, including results from two prospective...
Morgan Stanley Investment Management (MSIM) today announced an effort to convert eight municipal bond mutual funds into seven newly created exchange-traded funds (ETFs) and one existing ETF, representing nearly $10 billion in assets under management as of August 31, 2026. The Board of Trustees to the existing mutual funds approved the potential conversions, subject to approval by shareholders of each mutual fund and
Hyundai Motor Group hosts “HMG Autonomous Driving Media Day”, outlining its roadmap for the next era of autonomous driving; first showcase of Level 2++ technology Dual-Track strategy accelerates Level 2+ production through NVIDIA collaboration while internalizing key autonomous driving technologies through proprietary Atria AI ⋯NVIDIA solutions-based Level 2+ production targeted for the H1 2028 and Level 2++ in H2 2028, followed by Atria AI-powered Level 2++ vehicles in H2 2029 ⋯Progressive sensor standardization across Hyundai Motor, Kia, 42dot and Motional brings together autonomous driving capabilities across the Group Data Flywheel strategy establishes a virtuous cycle of data collection, training, validation and deployment to continuously advance AI capabilities ⋯Expands the Group’s data ecosystem by leveraging its annual sales of 7 million vehicles and Data Union framework, while implementing a data-centric development framework based on hard example mining, continuous training and SER ⋯Real-world Level 4 pilot to launch in Gwangju by year-end in partnership with Korea’s Ministry of Land, Infrastructure and Transport to secure large-scale validation data 42dot shares Vision-Language-Action (VLA)-based autonomous driving technology that integrates visual information and language-based reasoning to guide driving decisions ⋯VLA research focuses on addressing edge cases, while parallel development of end-to-end (E2E) autonomy and VLA models enhances technical stability and scalability ⋯VLA model validation currently underway, with on-road testing and the full development process scheduled to run through early next year New Atria AI urban driving videos — an executive ride-along, one-take footage, and edge-case handling — are live on the Group’s YouTube channel
Berlin, September 9, 2026 – Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib as a first-line treatment option for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI). “The FDA’s accelerated approval of sevabertinib marks an important advance for treatment-naïve patients with HER2-mutated NSCLC who historically have a poor prognosis,” said SOHO-01 lead investigator, Xiuning Le, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. “This milestone also underscores the critical importance of comprehensive molecular testing at diagnosis, including for activating HER2 mutations, to ensure patients receive the most appropriate treatment as early as possible.” The FDA approved this indication for sevabertinib under accelerated approval based on objective response rate (ORR) and duration of response (DOR) demonstrated in a cohort of treatment-naïve patients (N=69) in the ongoing Phase I/II SOHO-01 trial (NCT05099172), evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC. In this cohort, the ORR was 75% including complete responses in 6% of patients and partial responses in 70% of patients, with 73% of responders maintaining response for at least six months. The safety profile of sevabertinib was consistent with previous findings. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase III SOHO-02 confirmatory trial (NCT06452277), which is evaluating sevabertinib versus standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC. “Today’s FDA approval of sevabertinib as an initial treatment option for locally advanced or metastatic non-squamous HER2-mutated NSCLC is an important milestone for patients and a powerful validation of Bayer’s commitment to advancing precision oncology in areas with the highest unmet needs,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Lung cancer remains the leading cause of cancer-related deaths worldwide and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options. This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time.” In November 2025, sevabertinib received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial (from cohort D - previously treated patients who had not received HER2-targeted therapy and cohort E - patients who had previously received HER2-directed antibody-drug conjugates). Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. The approval follows the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation for this patient population. The CDE has also granted sevabertinib Breakthrough Therapy Designation to expedite its development for first-line use in patients with advanced HER2-mutant NSCLC. Sevabertinib has also recently been approved as the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment, by the Ministry of Health, Labour, and Welfare in Japan. About sevabertinib Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human HER2, including HER2 exon 20 insertions and HER2 point mutations. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs. Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with HER2-mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors with HER2-activating mutations, excluding advanced NSCLC. About Non-Small Cell Lung Cancer (NSCLC) Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
At the event in Saudi Arabia, AMD’s role helping governments, enterprises and partners build open AI infrastructure and turn investments into measurable business and economic value was on display.
Hyundai Hope on Wheels marks 28 years of impact with $303 million in lifetime giving Washington, D.C. events included handprint ceremonies and congressional reception Hyundai Hope on Wheels expands its global reach with planned launch in Sweden, followed by Spain and other countries Inaugural O’Brien/Reilly Spirit of Hope Award honors exceptional dealer leadership in the fight against pediatric cancer
Hyundai Motor Group Signs Historic Partnership Agreements with Oman’s Ministry of Transport, Communications and Information Technology The Group Teams Up with Mwasalat to Launch Oman's First Hydrogen City Bus in Muscat Oman Oil Marketing Company and EV Charging Brand EVO Join Forces with the Group to Build 240kW Ultra-Fast EV Charger Near Muscat Hyundai Kefico Formalizes EV Charging Test Cooperation with EVO Through New MOU
AMD, Saudi Arabia’s Ministry of Communications and Information Technology and Digital Cooperation Organization Launch an Open Developer Ecosystem to Advance AI Innovation
Cisco today launched its Sovereign Critical Infrastructure portfolio in Canada, giving greater control and choice over how organizations run their technology. More RSS Feeds: https://newsroom.cisco.com/c/r/newsroom/en/us/rss-feeds.html
Good policy starts with good conversations. eBay’s Government Relations team brings together sellers and policymakers to make both happen.