FDA raises questions to be considered at a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting discussing a Lexicon NDA for Zynquista ...
FDA and the Veterans Administration say they are partnering to open a virtual laboratory to evaluate health-related artificial intelligence applicatio...
FDA accepts for review a PTC Therapeutics NDA resubmission for Translarna (ataluren) and its use in treating nonsense mutation Duchenne muscular dystr...
FDA grants Prolong Pharmaceuticals a fast-track designation for PP-007 (PEGylated carboxyhemoglobin, bovine) and its use for treating acute ischemic s...
FDA accepts for review a Shanghai Henlius Biotech and Organon BLA for their biosimilar of Amgens Prolia/Xgeva (denosumab).
FDA warns Turkeys MedOffice Saglik Endustri Anonim Sirketi about CGMP violations in its manufacturing of finished drugs.
FDA releases a form FDA-483 with eight observations from an inspection at a Novo Nordisk drug substance manufacturing facility in Denmark.
FDA publishes a guidance setting an acceptable intake level for NITMA, a nitrosamine drug substance-related impurity, in products containing ritonavir...
