BioMarin Pharmaceutical says FDA is requesting results from an upcoming three-year data analysis from the ongoing Phase 3 GENEr8-1 study on its resubm...
FDA commissioner Robert Califf tests positive for Covid-19 while traveling over the weekend on agency business.
FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.
FDA updates the Health Care Provider Fact Sheet for Eli Lillys Covid-19 antibody therapy bebtelovimab to highlight expected reduced activity against c...
FDA releases a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.
Federal Register notice: FDA issues a final order to reclassify human immunodeficiency virus viral load monitoring tests from Class 3 to Class 2 (spec...
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to the Cleveland Clinic for two Covid-19 tests.
FDA extends by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitted that the agency ha...
