FDA asks the Oncology Drugs Advisory Committee to assess whether there is sufficient clinical trial data on Incytes retifanlimab to take regulatory ac...
Attorney Josephine Torrente says drug sponsors disagreeing with FDA over a Phase 3 protocol have no right of appeal and could consider using a special...
FDA warns Molecular BioLife it is marketing misbranded unapproved new drugs via a Web site.
Former FDA chief counsel Stacy Cline Amin joins Morrison & Foerster as a partner in its life sciences/healthcare practice.
Agios Pharmaceuticals files an NDA for mitapivat for treating adults with pyruvate kinase deficiency.
Researchers say FDA guidance on external controls in drug trials should be revised to reflect the use of retrospective natural history studies.
Federal Register notice: FDA announces for administrative purposes the issuance of an emergency use authorization to B. Braun Melsungen AG and the use...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals Givlaari (givosiran).