Press Release Fda Accepts New Drug Application And Grants Priority Review For Tlx101 Cdx Pixclara® Brain Cancer Imaging Agent

FDA awards 9 companies a new ‘national priority’ voucher to speed drug reviews

A gene therapy from Regeneron, a pancreatic cancer medicine from Revolution Medicines and a porphyria drug from Disc Medicine were among the first beneficiaries of a pilot program initiated in June. Read More

US FDA announces recipients of national priority vouchers

The U.S. Food and Drug Administration on Thursday announced the names of nine products, under a new fast-track review process, which could potentially get approval within one to two months of filing a ... Read More

FDA Grants Priority Review to Revuforj for Mutant NPM1 AML

Revuforj, a menin inhibitor, is under priority review for relapsed or refractory mutant NPM1 AML, with a target action date of October 25, 2025. The AUGMENT-101 trial demonstrated Revuforj's efficacy, ... Read More

FDA Doles Out First Nine Vouchers for Priority Drug Review

The nine companies selected to participate in the FDA Commissioner's National Priority Voucher (CNPV) pilot program have developed products that hold "significant potential to add ... Read More

FDA Picks Nine Drugs for Fast-Track Reviews in New Program

The US Food and Drug Administration on Thursday announced the first drug manufacturers that will receive expedited reviews as part of a new initiative to reward companies for acquiescing to the Trump ... Read More