2,115 press releases in English indexed under biotech & pharma.
The proposed proprietary name, or brand name, CIFBEZY has received conditional acceptance from the FDA and also federal trademark allowance from the USPTO These initial milestones will form the basis for the commercial identity of Acurx's lead product candidate, ibezapolstat, as the...
— ONC-783 is the first-and-only clinical-stage T-cell engager targeting a cancer-specific glycoform of CD24 (neoCD24) — — Subcutaneous formulation designed to provide gradual systemic exposure, potentially mitigating CRS risk — ROCKVILLE, Md., Aug. 17, 2026 -- OncoC4 Inc., a...
BEIJING, August 17, 2026--Sinovac Biotech Ltd. (NASDAQ: SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, today announced it filed its unaudited financial results for the six months ended June 30, 2026 with the U.S. Securities and Exchange Commission.
COPENHAGEN, Denmark, August 17, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, expands it pipeline of cancer vaccine programs with EVX-05 against the deadly brain cancer glioblastoma.
Up to $10 million debt financing supported by U.K. subsidiary VAT refunds and reimbursable R&D tax credits, including $5 million funded at the August 10, 2026 first closingFDA Type C Statistical Methods Meeting mid-September 2026 meeting to review 2.5-year Overall Survival data and confirmatory Phase 3 trial design to gain alignment on statistical analysis plan for BLA submission under the Accelerated Approval ProgramInterim 3-year Overall Survival data expected in early September 2026 ahead of...
As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, GAMP® 5 (Second Edition) risk-based validation, and cloud/SaaS deployments ensuring 21 CFR Part 11 and EU Annex 11 regulatory compliance remains paramount. This practical training course equips QA/QC professionals, IT system owners, and regulatory auditors with actionable methodologies for modernizing the System Development Life Cycle (SDLC), conducting critical-thinking risk assessments, writing IQ/OQ/PQ test protocols, maintaining data integrity, and establishing audit-ready documentation across the full system lifecycle. As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, GAMP® 5 (Second Edition) risk-based validation, and cloud/SaaS deployments ensuring 21 CFR Part 11 and EU Annex 11 regulatory compliance remains paramount. This practical training course equips QA/QC professionals, IT system owners, and regulatory auditors with actionable methodologies for modernizing the System Development Life Cycle (SDLC), conducting critical-thinking risk assessments, writing IQ/OQ/PQ test protocols, maintaining data integrity, and establishing audit-ready documentation across the full system lifecycle.
Opportunities include AI-enabled continuous inspection readiness, stronger GMP and data-integrity compliance, more effective CAPA and quality-culture systems, and training to help pharma and biotech firms meet evolving FDA expectations. Opportunities include AI-enabled continuous inspection readiness, stronger GMP and data-integrity compliance, more effective CAPA and quality-culture systems, and training to help pharma and biotech firms meet evolving FDA expectations.
Designed to help pharmaceutical and biotechnology organizations navigate evolving global regulatory expectations from the FDA, EMA, and MHRA, this intensive 2-day virtual seminar delivers practical strategies for designing, implementing, maintaining, and continually improving a robust Pharmaceutical Quality System (PQS). The course covers essential PQS frameworks based on ICH Q10 and ICH Q9(R1) Quality Risk Management, focusing on key operational components including Corrective and Preventive Action (CAPA) systems, change control, supplier quality management, process performance and product quality monitoring, and audit readiness to prevent compliance gaps. Designed to help pharmaceutical and biotechnology organizations navigate evolving global regulatory expectations from the FDA, EMA, and MHRA, this intensive 2-day virtual seminar delivers practical strategies for designing, implementing, maintaining, and continually improving a robust Pharmaceutical Quality System (PQS). The course covers essential PQS frameworks based on ICH Q10 and ICH Q9(R1) Quality Risk Management, focusing on key operational components including Corrective and Preventive Action (CAPA) systems, change control, supplier quality management, process performance and product quality monitoring, and audit readiness to prevent compliance gaps.
LOS ANGELES, Aug. 17, 2026 -- The DJS Law Group reminds investors of a class action lawsuit against Capricor Therapeutics, Inc. ("Capricor" or "the Company") (NASDAQ: CAPR) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated...
Montreal, Quebec--(August 17, 2026) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a publicly traded biotechnology company developing next-generation precision oncology therapeutics using its proprietary Accum® technology, is pleased to announce the appointment of Ryan Simms, PhD, as Chief Operating Officer ("COO") and Head of Radiopharmaceutical Programs, strengthening the Company's leadership and development capabilities as it...
TOKYO, August 17, 2026--Enhertu Showed Statistically Significant & Clinically Meaningful PFS Improvement as First-Line Treatment of Patients with HER2 Mutant Advanced NSCLC
VILLEJUIF, France, August 17, 2026--Regulatory News: Valerio Therapeutics (FR0010095596 - ALVIO), a biotechnology company pioneering next-generation precision-guided RNA therapeutics ("Valerio" or the "Company"), provides an update on the contemplated acquisition of 100% of the share capital of Etherna Immunotherapies NV ("Etherna") (the "Acquisition").