Janssen Pharmaceutical files an NDA for Xarelto (rivaroxaban), seeking its use in pediatric patients.
Federal Register notice: FDA makes available a final guidance entitled Chemistry, Manufacturing, and Controls Changes to an Approved Application: Cert...
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.