priority review voucher

FDA
Pharma

FDA 'proactively' awards J&J a national priority review voucher

The FDA granted the CNPV to J&J's combination of Tecvayli and Darzalex in multiple myeloma just a few days after a detailed phase 3 data presentation.
Angus Liu Dec 15, 2025 12:33pm
Michael McCaul

House vote moves FDA's rare PRV program a step closer to revival

Dec 2, 2025 11:22am
Makary
Favicon Fierce Biotech

2 lawmakers push for answers as questions swirl over FDA program

Nov 25, 2025 10:30am
accelerated
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Regeneron, Sanofi receive 1- to 2-month priority review vouchers

Oct 17, 2025 8:30am
Man hands gold dollar sign to another man

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

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

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

Jun 18, 2025 4:00am