News

Ophthalmology Times9d

Outlook Therapeutics requests Type A meeting with FDA following second CRL for ONS-5010

Outlook Therapeutics seeks FDA clarity on ONS-5010 after a complete response letter, aiming to address efficacy concerns for ...
STAT8dOpinion

The FDA’s pivot from ad comms to ‘expert’ panels is bad medicine

G. Caleb Alexander has chaired or served on more than a dozen FDA advisory committees. He’s worried the shift to ‘expert’ ...
Targeted Oncology2d

Positive FDA Type B Meeting Enables Development of Oz-V for Oropharyngeal Cancer

BioAtla's ozuriftamab vedotin advances to phase 3 trials for HPV-positive oropharyngeal cancer, aiming for accelerated FDA ...
TipRanks on MSN5d

Rapport Therapeutics plans to hold end-of-Phase 2 meeting with FDA in Q4

Rapport plans to hold an end-of-Phase 2 meeting with the U.S. Food and Drug Administration in the fourth quarter of 2025 and plans to initiate ...
Stockhead on MSN12d

Island submits key US FDA meeting request for new antiviral asset Galidesivir

Australian antiviral drug development company Island Pharmaceuticals has formally lodged a request for a Type C meeting for ...
NBC4 Columbus1mon

Cognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer’s Disease

PURCHASE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative ...
WGNO25d

FDA’s new expert panels are rife with financial conflicts and fringe views

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 ...