Hutchmed (HCM) announces that the supplemental new drug application for Orpathys has been granted approval by the China National Medical Products Administration, or NMPA, for the treatment of adult ...

The FDA met resistance from a three-judge panel Wednesday over its decision to refuse approval of Vanda Pharmaceuticals ...

Glaukos submitted a new drug application to the FDA for Epioxa ... a stronger UV-A irradiation protocol and supplemental oxygen. The NDA is supported by data from two phase 3 trials, both of ...

The sNDA is supported by data from the phase 3 ENERGIZE and ENERGIZE-T studies, which evaluated mitapivat vs placebo in patients with NTD and TD alpha- or beta-thalassemia, respectively.

Acalabrutinib with bendamustine and rituximab is now an FDA-approved treatment for patients with previously untreated mantle ...

Exelixis said it was notified by the Food and Drug Administration that its treatment for advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic will not be discussed at a meeting.

J&J announces a big deal to acquire neuroscience company ITCI for $14.6 billion, while Lilly and GSK announce smaller deals.

The oncology company said Thursday the supplemental new drug application for cabozantinib won't be discussed at an oncologic drugs advisory committee meeting. The application remains under ...

Apellis (APLS) stock jumped 8% Monday after the company announced preliminary Q4 and 2024 revenue results along with several ...