Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is, I believe, a ...

The FDA approved several therapies in oncology in the month of March 2025. These drugs included treatments for ...

Exelixis, Inc. EXEL announced that the FDA has approved the label expansion of its lead drug Cabometyx (cabozantinib). The ...

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...

The FDA approved Amgen ’s anti-CD19 therapy Uplizna Thursday for use in patients with IgG4-related disease. Uplizna is the ...

The approval follows the December 2024 priority review designation for this perioperative immunotherapy regimen for patients fighting muscle-invasive bladder cancer.

The FDA on Thursday gave the green light to Uplizna in IgG4-related disease, making it the first and only approved treatment ...

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.