Rep. Earl Blumenauer asks FDA to explain why it approved human trials for Elon Musks Neuralink medical device before inspecting its facility.
Two CDER Office of Clinical Pharmacology doctors use a podcast to explain a new guidance on considerations for antibody-drug conjugates.
The majority of U.S. Supreme Court justices appear skeptical during oral arguments on whether there should be a ban or any new restrictions on the abo...
Federal Register notice: FDA issues an order to debar Phillip Leonowens for a period of five years from importing or offering for import any drug into...
Federal Register notice: FDA announces support for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implem...
FDA issues a revised final and draft guidance on the handling and retention of BA and BE testing samples.
FDA warns Dr. Bret Rutherford about violations in his work as a clinical study investigator at the New York State Psychiatric Institute.
Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease following favorable...
