pharmaphorum October 17, 2025
The FDA has named the first products to take advantage of its recently announced Commissioner’s national priority voucher (CNPV) programme, a fast track for medicines that could deliver a decision on approval within one to two months.
The pilot scheme – for new medicines deemed to be of national priority as they could deliver breakthrough therapies to patients who urgently need them – will be put through its paces in reviews of nine medicines, including Merck KGaA’s fertility drug Pergoveris, which has also just announced a pricing deal for fertility medicines with the Trump administration.
The others include a new indication for Sanofi’s Tzield (teplizumab) in newly-diagnosed type 1 diabetes, Regeneron’s DB-OTO gene therapy for a form of congenital deafness,...
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