priority review

FDA

FDA drafts new policies to boost US drug production

Amid the administration's tariff updates and drug pricing deal, the FDA made moves this week to incentivize drug manufacturing in the U.S.

Fraiser Kansteiner Oct 3, 2025 3:52pm

speedometer accelerate fast speed push

Fierce Biotech

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

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

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