Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Beren Therapeutics P.B.C. ® (“Beren”) today announced that its subsidiary Mandos LLC ® (“Mandos”) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 years ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, ...

Revuforj, a menin inhibitor, is under priority review for relapsed or refractory mutant NPM1 AML, with a target action date of October 25, 2025. The AUGMENT-101 trial demonstrated Revuforj's efficacy, ...

A new drug-releasing system, TAR-200, eliminated tumors in 82% of patients in a phase 2 clinical trial for individuals with high-risk non-muscle-invasive bladder cancer whose cancer had previously ...