News

Merck granted FDA priority review for Winrevair label update
Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted priority review for its request ...
Applied Clinical Trials Online2d
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% ...
Fierce Pharma3d
Regulatory tracker: Merck nabs FDA priority review in bid to soup up Winrevair’s label
Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...
STAT18d
FDA announces a new priority review program in bid to further administration goals
The FDA is launching a program to reward companies with accelerated drug review and speedy agency feedback, if their actions ...
Fierce Pharma17d
Bavarian Nordic's $160M FDA speedy review voucher sale shows prices keep rising amid concerns over key program
The FDA approval of Vimkunya has given the chikungunya vaccine’s owner, Bavarian Nordic, an extra financial windfall. | The ...
MedPage Today on MSN11dOpinion
How Fast Is Too Fast for FDA Drug Review?
In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...
FierceBiotech18d
FDA debuts priority review voucher with 2-month timeline goal
The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency. The federal outfit’s ...