Approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1) The ...

Merck MRK announced that the FDA has approved both the intravenous (“IV”) and the subcutaneous (under the skin or SC) formulation of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), each in ...

The U.S. Food and Drug Administration (FDA) on Friday approved Merck & Co Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) for adult patients with resectable locally advanced head and neck squamous cell ...

FDA’s Approval of Keytruda for PD-L1 Positive Head and Neck Cancer Patients Signals a Clear Pathway for CEL-SCI’s Multikine to Address a Major Unmet Need in PD-L1 Negative Cancer Patients Provided by ...

Merck (NYSE:MRK) announced on Thursday that the FDA has granted priority review for two of its marketing applications aimed at expanding the U.S. indications of injectable and intravenous versions of ...

Keytruda's sBLA for LA-HNSCC treatment is under FDA priority review, with a decision expected by June 23. The KEYNOTE-689 trial showed significant improvements in event-free survival and major ...

Merck has obtained the Food and Drug Administration’s permission for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and ...

FDA approved Keytruda with Herceptin and chemotherapy for HER2-positive gastric/GEJ adenocarcinoma with PD-L1 expression. KEYNOTE-811 study showed improved progression-free and overall survival with ...

KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute RAHWAY, N.J.--(BUSINESS WIRE)-- Merck ...

The overall response rate was significantly higher for Keytruda plus chemotherapy versus chemotherapy alone (52% versus 29%). The approval marks first indication for Keytruda in MPM in the US, MPM is ...

Wednesday, the FDA approved Merck & Co Inc’s (NYSE:MRK) Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with ...