[ Price : $8.95]
FDA places a clinical hold on a BioMarin gene therapy study to treat adults with phenylketonuria.[ Price : $8.95]
FDA accepts for priority review a Global Blood Therapeutics supplemental NDA and a separate NDA for Oxbryta (voxelotor) and its us...[ Price : $8.95]
FDA clears a NeuroOne Medical Technologies 510(k) for its Evo sEEG Electrode technology for temporary (less than 24 hours) use for...[ Price : $8.95]
Attorney Sara Koblitz says the generic drug industry has been upended by a Federal Circuit Court of Appeals ruling that Teva induc...[ Price : $8.95]
FDA releases the FDA-483 with 10 observations from an inspection at Japans Toyobo Co.[ Price : $8.95]
Federal Register notice: A 10/28 advisory committee discusses whether an accelerated approval for an Oncopeptides NDA for Pepaxto ...[ Price : $8.95]
HHS restores FDAs authority to issues regulations without HHS authority, which was removed late in the Trump Administration.[ Price : $8.95]
FDA accepts for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating...