FDA approves Vertex Pharmaceuticals Kalydeco (ivacaftor) to include use in children with cystic fibrosis ages 12 to 24 months who have at least one mu...
FDA approves Grifols Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors.
Westminster Pharmaceuticals recalls all lots, within expiry, of its thyroid drugs levothyroxine and liothyronine because they were manufactured using ...
Federal Register notice: FDA announces a 9/20 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting that will discuss modernizin...
Office of New Drugs (OND) chief of staff Patrick Frey announces his departure to join Amgen as Global Regulatory Policy and R&D director.
FDA and NIH propose to relax some oversight of gene therapy trials to help expedite product development.
Federal Register notice: FDA reopens the comment period on a draft guidance entitled Elemental Impurities in Animal Drug Products Questions and Answe...
FDA announces a 9/20 advisory committee meeting to discuss modernizing its NDA assessments through a Knowledge-Aided Assessment and Structured Applica...