The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.

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

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 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.

Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for the ...

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 ...

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

The FDA has approved the combination of sotorasib (Lumakras) and panitumumab (Vectibix) for the treatment of patients with ...

Catalyst Pharmaceuticals settles patent litigation with Teva, delaying generic Firdapse launch until 2035. Legal actions against other defendants remain ongoing.

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.