News

The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one ...
The Food and Drug Administration announced the launch of a new program to fast-track agency approvals for drug manufacturers ...
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 ...
FDA unveils a priority voucher program to accelerate drug reviews for national priorities, using a team-based review model.
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 ...
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 ...
The U.S. Food and Drug Administration on Tuesday announced that it will issue a new priority review voucher to drug ...
FDA granted priority review to Zepzelca plus Tecentriq for first-line maintenance in extensive-stage small cell lung cancer.
Lurbinectedin plus atezolizumab significantly reduced the risk of disease progression or death by 46% compared with atezolizumab alone.
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 ...