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

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

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™ ...

The U.S. Food and Drug Administration has granted approval to Merck & Co. (NYSE:MRK) for the use of KEYTRUDA and KEYTRUDA QLEX, in combination with paclitaxel, with or without bevacizumab, to treat ...

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

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 ...

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 ...

Armed with what CEO Robert Davis called the “broadest and widest pipeline we’ve had in years,” Merck is preparing for its ...

Approval based on results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival versus ...