PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations...
FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspectio...
FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certain patients to receiv...
FDA has approved Arvinas Operations Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the first authorization...
FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy products. The CBER ...
FDA releases the form FDA-483 with three observations from an inspection at Indias Eugia Pharma Specialties Limited.
FDA proposes not to include semaglutide, tirzepatide, and liraglutide on the 503 Bulks List of drugs that can be legally compounded from bulk substanc...
The CDER Office of Prescription Drug Promotion cautions Bayer that a video and TV ad for its Nubeqa omit important risk information and contain elemen...
