FDA priority review

Imaavy
Pharma

J&J data set up Imaavy for expansion to treat anemic disorder

J&J has unveiled data from a trial which could pave the way for a label expansion for Imaavy to become the first therapy for a rare autoimmune disease
Kevin Dunleavy Jun 11, 2026 10:36am
FDA
Favicon Fierce Biotech

At CNPV hearing, industry support meets ‘concern’ from experts

Jun 5, 2026 5:00am
Sanofi

Sanofi asks out of FDA's CNPV program for Tzield expansion: Stat

May 6, 2026 4:00pm
opening door to brick wall
Favicon Fierce Biotech

Senate hearing takes aim at FDA's rare disease review process

Feb 26, 2026 3:50pm
Capitol Building and Congress

FDA’s rare pediatric voucher program revived by funding bill

Feb 4, 2026 3:12pm
FDA

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

Dec 15, 2025 12:33pm