PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations...
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 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...
Five Hogan Lovells attorneys discuss ways in which life sciences companies can use artificial intelligence in drug development and regulatory submissi...
The U.S. House Appropriations Committee votes to approve a spending bill to fund FDA for fiscal year 2027.
