FDA cites Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its quality control proce...
Intellia Therapeutics reports that a patient who experienced liver toxicity after being administered the companys CRISPR-based therapy nexiguran ziclu...
FDA approves Janssens Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with high-risk smoldering multiple myeloma (SMM), marking the fi...
Senate Democrats say they are worried that FDA and HHS may rely on partisan junk science during its recently announced review of the existing safety a...
FDA publicly releases an 11/4 complete response letter issued to Biohaven on its NDA seeking approval for troriluzole to treat spinocerebellar ataxia.
FDA extends by three months its review of Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) and its use in treating acquired hypoth...
FDA releases the form FDA-483 with six observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle, Westfalen, Germany...
FDA publishes 76 new and revised product-specific guidances intended to speed generic drug development and approval.
