The FDA will end a roughly nine-month hiatus of drug-related advisory committee meetings, with plans to convene its first session of 2026 to scrutinize a pair of oncology applications from AstraZen | ...

Aligned with FDA on dual-trial design Phase 3 program that aims to demonstrate robust efficacy and long-term safety and that allows for flexible ...

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

AtaiBeckley Inc. (NASDAQ:ATAI) is one of the best low cost stocks to buy under $5. On March 3, AtaiBeckley announced a successful End-of-Phase 2 meeting with the FDA regarding BPL-003, a proprietary ...

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today provided an update ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference at the Hubert Humphrey ...

The Food and Drug Administration is reviewing a request for new warnings on antidepressant drugs, and that's presenting an unusual conflict of interest at the agency.

WASHINGTON (AP) — When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert advisers who are carefully vetted for their independence ...