FDA warns Bend, OR-based ReNovo that its reprocessed single-use medical devices are adulterated and misbranded and have Quality System violations.
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...
Medline Industries recalls certain kits, trays and packs in direct response to Nurse Assists 11/2023 recall of 0.9% sodium chloride irrigation USP and...
FDA approves Johnson & Johnsons Opsynvi, a combination single tablet of macitentan and tadalafil for treating adults with pulmonary arterial hypertens...
