priority review voucher

shards of a disc in the air
Biotech

Disc's rare disease drug hit by FDA rejection

Disc’s bitopertin had hit the primary endpoint in what the FDA agreed was an adequate and well-controlled trial.
Capitol Building and Congress
Favicon Fierce Pharma

FDA’s rare pediatric voucher program revived by funding bill

Feb 4, 2026 3:12pm
Makary

2 lawmakers push for answers as questions swirl over FDA program

Nov 25, 2025 10:30am
accelerated

Regeneron, Sanofi receive 1- to 2-month priority review vouchers

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