FDA places a clinical hold on a BioMarin gene therapy study to treat adults with phenylketonuria.
FDA accepts for priority review a Global Blood Therapeutics supplemental NDA and a separate NDA for Oxbryta (voxelotor) and its use in treating sickle...
FDA clears a NeuroOne Medical Technologies 510(k) for its Evo sEEG Electrode technology for temporary (less than 24 hours) use for recording, monitori...
Attorney Sara Koblitz says the generic drug industry has been upended by a Federal Circuit Court of Appeals ruling that Teva induced infringement of a...
FDA releases the FDA-483 with 10 observations from an inspection at Japans Toyobo Co.
FDA Revire posts the Federal Register notices for the week ending 9/3/2021.
FDA review posts product approval summaries for the week ending 9/3/2021.
Federal Register notice: FDA renews its National Mammography Quality Assurance Advisory Committee for an additional two years beyond its charter expir...