The U.S. House of Representatives has given a unanimous thumbs up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December ...

As the FDA's Commissioner's National Priority Voucher (CNPV) program has picked up steam, with 15 companies now having ...

The FDA has granted priority review to a new drug application (NDA) seeking the approval of sonrotoclax (BGB-11417; BeOne ...

The FDA has now started a review of the highly anticipated drug, and AZ is using a priority review voucher to shorten the ...

A Prescription Drug User Fee Act target date of August 12, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) ...

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for baxdrostat for the add-on treatment of uncontrolled or treatment resistant hypertension in ...

New Drug Application, NDA, for baxdrostat has been accepted for Priority Review by the US Food and Drug Administration, FDA, ...

The FDA has started a priority review of BeOne Medicines' BCL2 inhibitor sonrotoclax in relapsed or refractory mantle cell ...

The FDA granted Welireg a priority review after it showed promising outcomes for patients with pretreated advanced renal cell carcinoma. The Food and Drug Administration (FDA) granted a priority ...

The Food and Drug Administration (FDA) has granted Priority Review to pegcetacoplan for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC ...

The U.S. FDA has revealed plans to launch a national priority voucher program aimed at reducing the drug review time period for selected manufacturers. The time to review a drug under the program will ...