Regeneron says the CHMP has recommended EU approval of an alternative Libtayo dosing schedule: 700 mg every six weeks after an initial 12-week regimen of 350 mg every three weeks. The opinion also supports an optional 15-30 minute infusion for eligible patients. The European Commission decision is expected in the coming months.
Novartis has received a positive CHMP opinion recommending European marketing authorization for Cosentyx (secukinumab) in adults with polymyalgia rheumatica, based on Phase III REPLENISH data showing sustained remission and steroid-sparing effects.
Novo receives a positive CHMP opinion for once-weekly Sogroya® (somapacitan) to treat children with idiopathic short stature in Europe.
Novo has secured a positive CHMP opinion for FREHEMGO® (denecimig) to treat haemophilia A in adults and children, offering the first FVIIIa mimetic with once-monthly, bi-weekly, and weekly dosing options in a pre-filled pen.
AstraZeneca and Daiichi Sankyo’s Datroway has received a positive CHMP recommendation in the European Union for the first-line treatment of adult patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.
Trodelvy mTNBC (sacituzumab govitecan-hziy) has reached a pivotal regulatory milestone in the European Union. On May 22, 2026, Gilead Sciences announced that the Committee for [Read More…]
GSK’s Blenrep combinations have received a positive opinion from the CHMP for treating relapsed/refractory multiple myeloma, backed by strong Phase III trial results showing improved survival outcomes.
