priority review

speedometer accelerate fast speed push
Favicon Fierce Biotech

FDA opens national priority fast track, offering 2-month reviews

The FDA has begun accepting applications for a fast-track pilot, giving medicines that align with U.S. priorities an accelerated route to market.
Nick Paul Taylor Jul 23, 2025 6:35am
Narasimhan

Novartis complies with FDA 'flexibility' ask in Pluvicto filing

Oct 29, 2024 10:51am
dupixent

FDA speeds Sanofi, Regeneron's application for Dupixent in COPD

Feb 22, 2024 11:25pm
Redbrick building with Sarepta name and logo

Sarepta's Elevidys expansion bid gets fast review without adcomm

Feb 16, 2024 11:05am
dengue fever

Takeda's dengue vaccine gets moved up in the FDA review queue

Nov 23, 2022 10:30am
FDA

Seagen's Tukysa picks up FDA priority review in Herceptin combo

Sep 20, 2022 10:59am