Drug Approval | May 25, 2026
Merck’s KEYTRUDA combo wins key EU backing for bladder cancer treatment
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
Clearance marks major shift beyond chemotherapy
The company said all doses achieved statistically significant reductions in body weight compared with placebo at 72 weeks
If cleared, MAVIRET would become one of the few therapies in the European Union approved to treat both acute and chronic hepatitis C infections
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
If approved, TEV-‘749 would mark a shift toward long-acting care aimed at improving treatment adherence in real-world settings
The decision marks a key step in the centralized EU review process
Clears major obesity endpoints at 80 weeks
SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization
Pfizer says the broader dataset across all 25 serotypes strengthens confidence that the program can meet non-inferiority thresholds in its upcoming Phase 3 pediatric trials
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