PDUFA

clock delay wait time alarm

Biotech

Regenxbio's Hunter gene therapy latest to face FDA delay

The review extension and request for more data bears the fingerprints of recently returned CBER head Vinay Prasad, M.D.

Darren Incorvaia Aug 19, 2025 10:30am

plan B fail reroute road path trail miss

FDA delays Omeros' 2nd attempt at transplant drug’s approval

Aug 15, 2025 5:55am

Graphic image of a red thumbs down against a blue background

FDA rejects Capricor’s DMD cell therapy, asks for more data

Jul 11, 2025 9:18am

Clock in front of the subway

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

Jun 18, 2025 4:00am

FDA stop sign

FDA's 'heavy workload' blamed for delaying KalVista's PDUFA date

Jun 16, 2025 4:33am

red tape delay stop error tie down stall

FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am