The CHMP has recommended nemolizumab’s approval for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic ...

As Eisai and Biogen can attest, European regulators are cautious about the safety concerns of Alzheimer’s drugs. The partners’ Kisunla-rivaling Leqembi eventually won CHMP’s favor in ...

Among its positive recommendations, Europe’s CHMP has blessed ExCellThera’s Zemcelpro, a first-of-its-kind treatment for adults with blood cancers.

On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two ...

In a note sent to investors Monday, William Blair analyst Sami Corwin said the European Commission decision to not adopt the CHMP opinion and instead return the matter to the committee is ...

The CHMP positive opinion is based on data from the pivotal placebo-controlled Phase 3 VANGUARD trial and its open-label extension study, both evaluating the efficacy and safety of garadacimab.