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BioMarin Pharmaceutical says FDA is requesting results from an upcoming three-year data analysis from the ongoing Phase 3 GENEr8-1...[ Price : $8.95]
FDA commissioner Robert Califf tests positive for Covid-19 while traveling over the weekend on agency business.[ Price : $8.95]
FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.[ Price : $8.95]
FDA updates the Health Care Provider Fact Sheet for Eli Lillys Covid-19 antibody therapy bebtelovimab to highlight expected reduce...[ Price : $8.95]
FDA releases a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical...[ Price : $8.95]
Federal Register notice: FDA issues a final order to reclassify human immunodeficiency virus viral load monitoring tests from Clas...[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to the Cleveland Clinic for two Covid-19 tests.[ Price : $8.95]
FDA extends by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitte...