#priority review

2 stories

Regulatory April 4, 2026 · View digest

Rusfertide Receives FDA Priority Review for Polycythemia Vera

Takeda/Protagonist Therapeutics' rusfertide, a first-in-class hepcidin mimetic peptide, received NDA acceptance and priority review. The Phase 3 VERIFY study showed it more than doubled clinical response rates.

Regulatory April 3, 2026 · View digest

FDA Approves Foundayo Under National Priority Voucher Program in Record 50 Days

Foundayo became the first new molecular entity cleared under the Commissioner's National Priority Voucher Program, with review completed 294 days before the PDUFA date. Commercial pricing set at $25/month insured and $149/month self-pay at the lowest dose.