The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.

ZNTL stock gains as the FDA lifts clinical hold on studies of its lead candidate, azenosertib, which is being developed for different cancer...

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

CRVS stock gains 14% on initiating a registrational study on its lead candidate, soquelitinib, to treat relapsed/refractory peripheral T-cell...

XNCR moves four new XmAb drug development programs for autoimmune diseases. It also provided favorable updates for two of its oncology drug...

Shares of PRAX gains on positive efficacy data from the mid-stage study of its investigational candidate, relutrigine, for two epilepsy indications.

Shares of PRAX gains on positive efficacy data from the mid-stage study of its investigational candidate, relutrigine, for two epilepsy indications.

The FDA okays AstraZeneca's Fasenra for treating adults with eosinophilic granulomatosis with polyangiitis. This is the second approved indication for...

NEW YORK, Sept. 13 (Xinhua) -- The U.S. Food and Drug Administration (FDA) plans to propose labeling this fall for the front of food and drink...