Federal Register notice: FDA announces its fiscal year 2025 CDER Office of Pharmaceutical Quality Experiential Learning Site Visit Program.
FDA gives accelerated approval to Novartis Fabhalta for reducing proteinuria in primary IgA nephropathy.
FDA clears a Huxley Medical 510(k) for at-home sleep apnea diagnostic patch, Sansa.
FDA publishes a draft guidance on developing drug and biological treatments for a specific bladder cancer.
FDA approves a Citius Pharmaceuticals BLA for Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory cutaneous T-cell lymphoma.
FDA approves a Purdue Pharma NDA for Zurnai, a nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose...
FDA approves Medtronics Simplera disposable continuous glucose monitor.
Federal Register notice: FDA announces a 9/9 Antimicrobial Drugs Advisory Committee meeting to discuss an Iterum Therapeutics NDA for its urinary trac...
