Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) urge FDA to finalize a proposed rule on making certain hearing aids available over the coun...
FDA extends by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clinical Type 1 diabetes ...
Federal Register notice: FDA proposes to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from Clas...
Pfizer submits an NDA to FDA for Paxlovid to treat Covid-19 patients at high risk for progression to serious illness.
Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-P...
Sanofi says enrollment in a Phase 3 tolebrutinib trial has been paused due to an FDA partial clinical hold.
Federal Register notice: FDA determines that Janssen Pharmaceuticals Micronor (norethindrone tablets), indicated for preventing pregnancy, was not wit...
Five drug companies recommend changes to an FDA draft guidance on developing drugs to treat ulcerative colitis.