FDA clears a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope.
FDA says it will give priority review to a Servier sNDA seeking a new indication for Tibsovo to treat some adult myelodysplastic syndrome patients.
The Fifth Circuit Court of Appeals rules that the abortion drug mifepristone can remain on the market while litigation continues.
Attorney Douglas Farquhar says an FDA trend toward more enforcement discretion for drug company inspections with official action indicated results may...
The FDA National Center for Toxicological Research says initial results from its new PathologAI initiative in preclinical animal studies are encouragi...
Federal Register notice: FDA announces a 10/4 Oncologic Drugs Advisory Committee meeting to review a World Meds NDA eflornithine tablets for reducing ...
Federal Register notice: FDA makes available a final guidance entitled Informed Consent: Guidance for Institutional Review Boards, Clinical Investigat...
Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medicated articles.
