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.
FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.
