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Federal Register notice: FDA seeks comments on an information collection extension entitled Certification of Identity; Form FDA 39...[ Price : $8.95]
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]
Federal Register notice: FDA makes available a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Pr...[ Price : $8.95]
Federal Register notice: FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.[ Price : $8.95]
A Phase 3 trial of GSKs accelerated-approved Blenrep (belantamab mafodotin) in patients with relapsed or refractory multiple myelo...[ Price : $8.95]
FDA slaps a clinical hold on a Verve Therapeutics IND for its VERVE-101 in patients with heterozygous familial hypercholesterolemi...