FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent year...
FDA selects seven companies from 80 applications to participate in the agencys PreCheck Pilot Program to advance U.S. drug manufacturing.
FDA warns Genzyme Ireland about the failure of the firms quality control unit to ensure that drugs comply with CGMP requirements.
During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...
FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that...
Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could change the way that supp...
FDA publishes a guidance on submitting next-generation sequencing data to CDERs Division of Antivirals.
FDA warns Indias Wizcure Pharmaa about CGMP violations in its production of over-the-counter drugs.
