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 ...

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

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.

The FDA granted priority review to the combination of lurbinectedin and atezolizumab as a first-line maintenance therapy for ...

Azstarys (AK0901) is the first and currently the sole globally approved ADHD combination therapeutic pairing immediate-release dexmethylphenidate (d-MPH) with the prodrug serdexmethylphenidate (SDX).

Priority Gold makes acquiring precious metals ... This is reflected in the company’s positive reviews across multiple independent platforms. This includes an A+ rating from the Better Business ...

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 ...

Against the stark backdrop of the FDA job cuts, stakeholders in the rare disease space find themselves facing heightened uncertainty. In late March 2025, the Trump administration moved forward ...