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 FDA is introducing a ...

The FDA is launching a program to reward companies with accelerated drug review and speedy agency feedback, if their actions ...

The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...

The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one ...

Investing.com -- The U.S. Food and Drug Administration has introduced a new Commissioner’s National Priority Voucher (CNPV) ...

(Reuters) -The U.S. Food and Drug Administration on Tuesday announced that it will issue a new priority review voucher to ...

FDA granted priority review to Zepzelca plus Tecentriq for first-line maintenance in extensive-stage small cell lung cancer.

During the program’s first year, the FDA plans to issue a limited number of vouchers to companies aligned with U.S. national health priorities, which include addressing health crises, delivering ...

Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) ...

Regulatory action was based on data from the Phase III IMforte trial, which showed that Zepzelca plus Tecentriq significantly ...

China NMPA accepts and grants priority review status to ArkBio's NDA for Azstarys to treat ADHD in patients aged six years and above: Shanghai, China Tuesday, June 17, 2025, 10:00 ...

The U.S. Food and Drug Administration has revealed plans to launch a national priority voucher program aimed at reducing the ...