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 ...

Jazz Pharmaceuticals (NASDAQ:JAZZ) announced Tuesday that the U.S. Food and Drug Administration (FDA) granted priority review ...

Lurbinectedin plus atezolizumab significantly reduced the risk of disease progression or death by 46% compared with atezolizumab alone.

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

The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca's supplemental biologics licence application (sBLA) for Imfinzi (durvalumab), a human monoclonal antibody ...

A Prescription Drug User Fee Act target date of July 28, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has granted Priority Review to pegcetacoplan for the ...

The Food and Drug Administration’s rare pediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations since 2012, is doomed to disappear ...