Imugene has landed a prized FDA orphan drug approval for its bile tract cancer therapy following positive results from its recent metastatic advanced...

Imugene has landed a prized FDA orphan drug approval for its bile tract cancer therapy following positive results from its recent metastatic advanced...

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...

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

REGN gets FDA nod for Dupixent for a broader population for the indication of chronic rhinosinusitis with nasal polyps.

The FDA approves NVS' Kisqali to reduce the risk of disease recurrence in patients with HR+/HER2- early breast cancer.

NVS' breast cancer drug Kisqali reduces the risk of disease recurrence by 28.5% in a broad population of patients suffering from early breast cancer.

Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.