FDA Ties Amgen's Tavneos to Eight Deaths and 76 Liver Injury Cases on April 03, 2026 Amgen ANCA vasculitis bile duct syndrome DILI drug safety Injury of liver Tavneos United States Food and Drug Administration +
AI is Transforming Drug Safety—But Governance Sets Essential Guardrails on October 09, 2025 Adverse reaction to drug AI guardrails Artificial Intelligence Bias (Epidemiology) Data Integrity drug safety Jeavons syndrome Pharmacovigilance regulatory governance United States Food and Drug Administration +
FDA Begins Daily Publication of Drug Adverse Event Data on August 25, 2025 Adverse event Daily data modernization drug safety FAERS public health medicine (field) real-time monitoring United States Food and Drug Administration +
Schrödinger Halts SGR-2921 Leukaemia Programme After Two Deaths on August 14, 2025 CDC7 protein, human clinical trial halt drug safety Inhibitor Leukemia Leukemia, Myelocytic, Acute MYELODYSPLASTIC SYNDROME patient deaths Schrödinger SGR-2921 +
Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs on July 22, 2025 AP01 AP02 aspects of adverse effects Avalyn Clinical Trials drug safety Holdings inhaled lung disease nintedanib Pharma pirfenidone Pulmonary Fibrosis Series D SNCG gene Suvretta Capital Management +
Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments on July 21, 2025 AAVrh74 CHARGE Syndrome drug safety Elevidys gene therapy Muscular Dystrophy, Duchenne patient deaths Regulatory Action Ships Suspensions United States Food and Drug Administration +
FDA Advisory Committee Votes Against GSK's Blenrep in Multiple Myeloma on July 17, 2025 Advisory Committees Clinical Trials drug safety Eye Multiple Myeloma ODAC SmithKline Beecham Toxicity aspects United States Food and Drug Administration vote +
Mayne Pharma Faces FDA Action Over 'Misleading' Drug Safety Claims Ahead of $430M Buyout on May 16, 2025 claims Contraceptives Cosette Pharmaceuticals drug safety Mayne Nextstellis Oral Pharma United States Food and Drug Administration +
Former FDA Officials Sound Alarm: Visible Changes May Be Tip of the Iceberg on April 17, 2025 Alarm device Changing Disease Outbreaks drug safety Icebergs KAT5 wt Allele Leadership Policy Previous public health medicine (field) United States Food and Drug Administration Vaccines Visible +
EU PFAS Ban Threatens Pharmaceutical Packaging Industry: Challenges and Implications on February 20, 2025 chain disruption chemical alternatives drug safety environmental EU PFAS gene Pharmaceutical Packaging regulatory +