FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspectio...
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...
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.
FDA approves an expanded use for Axsome Therapeuticss Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associat...
