EU & US At Odds Over Merck’s Keytruda
Decisions Show How Regulators Can Differ Over Same Data
EU and US regulators have opposing views when it comes to Merck's applications for a new indication and new dosing schedule for the company's successful PD-1 inhibitor Keytruda.
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keytruda is set to remain dominant despite knockback, though Tecentriq could claim prized NSCLC adjuvant approval first
Opdivo showed a 23% fall in the risk of death and 2.5-month improvement in median overall survival compared to chemotherapy in Phase III esophageal cancer trial.