United States Food and Drug Administration
Exclusive: Compounding giant Empower Pharmacy cuts hundreds of staff, stops New Jersey operations
Empower Pharmacy; compounding pharmacy; layoffs; job cuts; New Jersey operations; East Windsor facility; manufacturing shutdown; outsourcing facility; FDA inspection; Form 483; compounded GLP-1 drugs; workforce reduction
FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations
Marty Makary; FDA; COVID-19 vaccine; myocarditis; vaccine deaths; safety warnings; RFK Jr.; mRNA vaccines
GSK wins FDA approval for ultra-long-acting asthma drug Exdensur (depemokimab)
GSK; Exdensur; depemokimab; FDA approval; severe asthma; ultra-long-acting biologic; twice-yearly dosing; type 2 inflammation; eosinophilic phenotype; IL-5 inhibitor
Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery
Medivis; FDA 510(k) clearance; augmented reality; AR navigation; cranial neurosurgery; intraoperative guidance; cranial navigation platform; external ventricular drain; ICU bedside procedures; surgical intelligence; spine navigation; neurosurgery innovation
FDA Advances Real-World Data Use and Early-Phase Trial Reforms to Accelerate Drug Approvals
FDA; real-world data; real-world evidence; RWE; early-phase trials; drug approval; Marty Makary; Trump
J&J’s Tecvayli and Darzalex Combo Wins FDA’s Proactive National Priority Voucher for Relapsed/Refractory Multiple Myeloma
J&J; FDA; National Priority Voucher; Tecvayli; Darzalex; Multiple Myeloma; CNPV; ASH 2025
The 5 Most Painful Clinical Trial Failures of 2025
clinical trial failures; 2025; biotech; gene therapy; MS; DMD; FDA approvals
FDA Approves Enhertu-Perjeta Combo for First-Line Treatment of HER2+ Metastatic Breast Cancer
Enhertu; Perjeta; FDA approval; HER2-positive; metastatic breast cancer; first-line
Kyverna to seek FDA engagement after positive autoimmune CAR-T data in stiff person syndrome
Kyverna; KYV-101; CAR-T; autoimmune disease; stiff person syndrome; SPS; FDA; regulatory path; cell therapy
Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay
Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback