FDA posts the establishment inspection report with seven observations from a 2023 inspection at a Boehringer Ingelheim drug manufacturing facility in ...
FDA approves the removal of an imaging contraindication on Abbotts FreeStyle Libre 2 and 3 continuous glucose monitoring systems.
Federal Register notice: FDA makes available additional revised draft product-specific guidances that provide recommendations on bioequivalence study ...
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).
