The approvals stem from the Phase III KEYNOTE-B96 trial data, which was presented at the 2025 ESMO Congress.

But now, 13 years after the FDA initially blessed it for skin cancer, the U.S. regulator has approved Keytruda as a second- ...

FDA approves pembrolizumab with chemotherapy for platinum-resistant ovarian cancer, showing significant survival benefits in ...

The U.S. Food and Drug Administration (FDA) on Wednesday approved Merck & Co. Inc.’s MRK Keytruda (pembrolizumab) and ...

ImmunityBio Executive Chairman Patrick Soon-Shiong criticized the FDA for applying tougher approval standards to Anktiva than to Merck’s Keytruda. ・He said regulators allowed Keytruda to expand across ...

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ ...

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 ...

FDA approved a PD-L1 companion test to identify patients with ovarian, fallopian tube or primary peritoneal cancer who may receive first-line Keytruda. The U.S. Food and Drug Administration (FDA) has ...

FDA clearance covers pembrolizumab plus paclitaxel ± bevacizumab for PD-L1 CPS ≥1 platinum-resistant disease after one or two prior systemic regimens, introducing PD-1 inhibition into this treatment ...

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 ...

Canada's health regulator has approved Merck's new under-the-skin version of its cancer drug Keytruda, offering an alternative to the current intravenous infusion. Health Canada has approved Keytruda ...