The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for SL1009 (sodium dichloroacetate oral solution) for the treatment of pyruvate dehydrogenase complex ...

The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.

Replimune Group ( REPL, Financials) shares surged 17% to $11.85 as of 10:18 a.m. ET Tuesday after the U.S. Food and Drug Administration granted Priority Review for its Biologics License Application ...

Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk ...

The FDA grants Priority Review to applications for medicines that ... with approximately 100,000 new cases and 8,000 deaths estimated in the U.S. in 2024. i Standard of care therapy includes treatment ...

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...