FDA approves Janssen Biotechs Simponi Aria (golimumab) for treating adults with active psoriatic arthritis and active ankylosing spondylitis.
FDA approves a GlaxoSmithKline BLA for its Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoster) in adults aged 50...
Octapharma USA withdraws two lots of Octagam 10% [immune globulin intravenous (human)] liquid preparation] that is labeled with lot numbers K724B8541 ...
FDA approves an AstraZeneca NDA for Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation designed for an improved once...
Federal Register notice: FDA determines that AstraZenecas Elavil (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 1...
FDA Review posts the Federal Register notices for the week ending 10/20/2017.
FDA posts 51 product-specific guidances (32 new and 19 revised) describing the agencys current thinking and expectations on how to develop certain gen...
FDA says it is paying equal attention to medical device manufacturers struggling alongside drug makers in Puerto Rico as they work to return productio...