FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant on September 24, 2025 Cautionary Warning Incheon Janssen Vaccines Korean language Plants production quality control violations spotty complaint reporting United States Food and Drug Administration vial stopper defects +
Eli Lilly Picks Houston for $6.5 Billion API Manufacturing Facility on September 24, 2025 alpha 1-antitrypsin cardiometabolic Eli Eli Lilly Generation Park Houston Immunology Investments manufacturing Neoplasms Neuroscience discipline pharmaceutical manufacturing small molecule medicines +
FDA Delays Decision on Sanofi's Oral Multiple Sclerosis Drug to December 2025 on September 24, 2025 BTK inhibitor Clinical action December 2025 drug review Multiple Sclerosis nrSPMS PDUFA sanofi Tolebrutinib United States Food and Drug Administration +
Parkinson’s Patients Prefer Medtronic’s Adaptive Brain Stimulation Over Traditional Settings, Major Study Shows on September 24, 2025 ADAPT-PD study adaptive deep brain stimulation aDBS Approved Deep Brain Stimulation Medtronic Parkinson 's disease personalized neuromodulation United States Food and Drug Administration +
FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome on September 24, 2025 3-Methylglutaconic aciduria type 2 Accelerated Approved Elamipretide Forzinity Infrequent Mitochondrial Diseases Pediatric Disorder Stealth BioTherapeutics United States Food and Drug Administration +
BMS Breaks Clinical Losing Streak with Positive Phase 3 Myeloma Readout for Iberdomide on September 24, 2025 CELMoD Clinical Trials EXCALIBER-RRMM iberdomide Minimal Residual Disease Negativity Multiple Myeloma Myers Progression-Free Survival Protein Degradation, Metabolic squibb +
Seres Therapeutics Cuts 25% of Workforce Following FDA Feedback on Microbiome Therapy Trial on September 24, 2025 Biopharma cash runway Clinical Research Feedback - system communication layoffs Microbiome Microbiome SER-155 Seres United States Food and Drug Administration +
FDA Rejects Scholar Rock's SMA Drug Due to Catalent Indiana Manufacturing Issues on September 23, 2025 apitegromab Catalent Indiana Complete Drug Approval manufacturing issues Response Letter Scholar Rock SMA Spinal Muscular Atrophy United States Food and Drug Administration +
FDA Rejects Lundbeck and Otsuka's Rexulti for PTSD on Insufficient Efficacy Evidence on September 23, 2025 brexpiprazole Clinical Trials Complete Drug Approval Lundbeck Otsuka Post-Traumatic Stress Disorder Response Letter Rexulti sertraline sNDA United States Food and Drug Administration +
Roche’s Top Three Ambition in Obesity Not Dependent on a Single Megablockbuster on September 23, 2025 cardiometabolic care diagnostics digital health Ecosystem Obesity Portfolio diversification Roche (company) Weight-Loss Agents +
Celltrion Acquires Eli Lilly’s New Jersey Manufacturing Site for $330 Million on September 23, 2025 Acquisition biopharmaceutical manufacturing Biosimilars Celltrion Contract agreement Eli Lilly Investments Jersey site supply chain US tariffs +
Fierce Biotech Fundraising Tracker '25: Avenzo adds $60M Series B; Ollin debuts with $100M on September 23, 2025 Antibodies, Bispecific Avenzo Clinical Trials Neoplasms Ollin Biosciences Ophthalmology specialty Pipeline Development Series B financing venture capital +
Roche's Oral SERD Achieves Progression-Free Survival Milestone in Pivotal Breast Cancer Trial on September 23, 2025 advanced breast cancer Clinical Research ER-positive giredestrant Hormone Therapy Malignant neoplasm of breast oral SERD Phase 3 Clinical Trials Progression-Free Survival Roche (company) +