FDA grants Janssen Pharmaceutical a breakthrough therapy designation for niraparib, an orally-administered poly ADP-ribose polymerase inhibitor, for t...
Public Citizen challenges President Trumps assertion that his actions are responsible for lower drug prices.
Federal Register notice: FDA makes available a final guidance entitled Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.
The Taxpayers Protection Alliance calls on FDA to make changes in its regulation of drugs, tobacco, and foods to promote innovation and save consumers...
FDA announces availability of a technical specifications guidance with bioanalytical methods templates.
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...