Browse press releases
The newest releases come first, each with its full text here and a link to its original. Try the filters to narrow them down.
- OS TherapiesOS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory UpdatesUp 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...
- Computer System Validation (CSV) Implementation Boot Camp: Practical Validation of GxP Computerised Systems (Aug 19th - Aug 21st, 2026)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organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, GAMP® 5 (Second Edition) risk-based validation, and cloud/SaaS deployments ensuring 21 CFR Part 11 and EU Annex 11 regulatory compliance remains paramount.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.
- FDA Inspection Readiness in the AI Era 2026 (Aug 20th - Aug 21st, 2026)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.
- 2-Day Virtual Seminar: Practical ICH Q10 Pharmaceutical Quality System (PQS) Implementation for FDA Compliance & Inspection Readiness (August 26–27, 2026)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.
- DJS Law Group LLPCapricor Therapeutics, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - CAPRThe 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...
- Defence Therapeutics Inc.Defence Therapeutics Strengthens Radiopharmaceutical Leadership with Appointment of Dr. Ryan Simms as Chief Operating Officer and Head of Radiopharmaceutical ProgramsDefence 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...
- Enhertu® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival as First-Line Treatment of Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 TrialTOKYO, August 17, 2026--Enhertu Showed Statistically Significant & Clinically Meaningful PFS Improvement as First-Line Treatment of Patients with HER2 Mutant Advanced NSCLC
- Valerio Therapeutics and Etherna Immunotherapies Progress Towards Finalisation of Transaction Documentation Regarding the Contemplated AcquisitionVILLEJUIF, 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").
- Zelluna ASA: Notice of EGM – experienced international biotech executive proposed for election to the Board and Board member steps downOslo, 17 August 2026: The Board of Directors of Zelluna ASA (the “Company”) hereby calls for an Extraordinary General Meeting to be held on 9 September 2026 at 13:00 CEST, regarding election of a new member of the Company’s Board of Directors (the “Board”).
- Mesoblast Achieves Major Milestone Completing Patient Treatment in Pivotal Phase 3 Trial for Chronic Low Back PainMesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has completed patient treatment in the MSB-DR004 pivotal randomized controlled Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with the inflammatory condition of degenerative disc disease. The major milestone was achieved with 350 patients randomized and treated with either an intra-discal injection of rexlemestrocel-L or sham injection. Total patient numbers treated increased from 300 to 350 after strong demand from trial investigators to have their patients enrolled in the innovative program.
- THE ROSEN LAW FIRM, P. A.SPRY Investors Have Opportunity to Lead ARS Pharmaceuticals, Inc. Securities Fraud LawsuitWhy: Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of securities of ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) between March 9, 2026 and June 24, 2026, inclusive (the "Class Period"). A...
- AbelZeta Pharma, Inc.AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in Large B-cell LymphomaAbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that...