US regulators have withdrawn their approval of a GSK Plc drug that the Trump administration had promoted as a treatment for ...
The ​U.S. ‌Food and ​Drug ​Administration ⁠on ​Friday declined ​to approve ​Replimune's ​drug for ‌advanced ⁠skin cancer, ...
FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage ...
A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S.
FDA launches new AI-powered system to track drug and vaccine side effects in real time, replacing outdated databases and ...
The FDA granted Priority Review to the supplemental BLA (sBLA) for efgartigimod alfa-fcab for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia ...
US Food and Drug Administration (FDA) officials credited recent advancements in regulatory science and flexibilities with ...
On Thursday, U.S. Senator Richard Blumenthal (D-CT) and Connecticut Attorney General William Tong (D) sent a letter to the ...
The FDA’s decision to extend the labeled duration of faricimab use in RVO beyond 6 months primarily reflects accumulated evidence supporting its continued efficacy and safety over longer treatment ...
A drug long used to fight cancer may soon take on a very different role. Researchers at the University of Illinois Chicago ...