FDA priority review

accelerated
Biotech

FDA aims for September approval decision for Stealth's drug

The newfound urgency is likely fueled by a public outcry surrounding the FDA's several delays and subsequent refusal of the rare disease candidate.
Gabrielle Masson Aug 21, 2025 10:15am
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Favicon Fierce Pharma

Bavarian Nordic's $160M PRV price reflects new realities

Jun 18, 2025 11:47am
Clock in front of the subway

FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am
Magnifying glass with pills on blue

FDA debuts priority review voucher with 2-month timeline goal

Jun 17, 2025 11:59am
rare diseases

Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm
gymnastics

Vertex meets own cystic fibrosis record with next-gen treatment

Feb 5, 2024 7:50pm