FDA approves Mercks Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Regarding Global Unique...
Federal Register notice: FDA makes available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products.
FDA releases the FDA-483 with five inspection observations issued following an inspection at Revance Therapeutics.
FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in ad...
FDA grants Varian a breakthrough device designation for its Embozene microspheres for genicular artery embolization in treating symptomatic knee osteo...
FDA posts a draft guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.
Federal Register notice: FDA announces a 10/26 Vaccines and Related Biological Products Advisory Committee meeting to review and discuss Pfizer-BioNTe...