A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments is not supported by ...
FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding Project Orbis from ...
FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operative guidance for trans...
Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer complaint indicating that ...
FDA warns Boston, MA-based Whoop that it is illegally marketing an unapproved medical device that estimates blood pressure, despite being cautioned by...
A Phase 3 clinical trial evaluating Alexions anselamimab for light chain amyloidosis fails to meet its primary endpoint, but shows significant clinica...
FDA releases a funding opportunity for natural history studies to advance product development in rare diseases and conditions.
FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.
