FDA approves Gilead Sciences Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in certain at-risk adults and adolescents for HIV-...
Nippon Shinyaku completes submission of a rolling NDA for viltolarsen, a Duchenne muscular disease drug that is amenable to exon 53 skipping.
FDA clears a Biofourmis 510(k) for its machine-learning and artificial intelligence-powered Biovitals Analytics Engine as a medical device for ambulat...
Federal Register notice: FDA corrects a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products because it contained an i...
FDA denies a Zydus petition asking it to take certain actions regarding new applications citing Mephyton as the reference-listed-drug.
FDA grants Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma.
FDA debuts a Web page dedicated to FY 2018 GDUFA science and research outcomes.
BioCentury reports that President Trump will nominate MD Anderson Cancer Center chief medical officer Stephen Hahn to be the next FDA commissioner.