EU clears first PD‑1 inhibitor plus ADC regimen for resectable muscle‑invasive bladder cancer regardless of cisplatin eligibility; phase 3 showed EFS HR 0.53 and OS HR 0.65.
CHMP recommends approval after KEYNOTE-B15 showed event-free survival, overall survival and pathologic complete response gains; European Commission decision expected Q4 2026.
Phase 3b data indicate a single Bexsero booster at age 10+ boosts immunity in those primed in infancy; full study results will be presented at IPNC in September.
EU selects fourth common auction platform for its emissions trading system; auctions begin 2027 and ETS2 auctioning starts January 2027 while ETS2 operations start in 2028.
CHMP backed perioperative regimen for cisplatin‑ineligible resectable MIBC after Phase 3 KEYNOTE‑905 showed significant EFS, OS and pCR gains; EC decision due by Q3 2026; FDA cleared Nov 2025.
EU CHMP backs expanded WINREVAIR™ use for PAH, covering WHO FC II-IV. Decision by European Commission expected Q1 2026.
KEYTRUDA SC, a subcutaneous immune checkpoint inhibitor, is approved in Europe for faster administration across all adult indications.
ENFLONSIA™ awaits EU approval for infant RSV prevention, offering a single-dose option for all weights. Backed by Phase 2b/3 and Phase 3 trials, decision expected by year-end.
CHMP backs KEYTRUDA SC for all EU adult indications and a new use in LA-HNSCC. Awaiting European Commission's final decision.
