Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi ...

Biogen BIIB and partner Eisai announced that the European Commission (EC) has granted marketing authorization to Leqembi ...

It also means that most regulatory watchers may not be looking at the appropriate endpoint for calculating and comparing relative cycle times. In most cases, the EC agrees with the CHMP's ...

Leqembi gains European approval after CHMP reversal, despite safety concerns tied to brain swelling and bleeding in Alzheimer ...

Well, the company has received a major regulatory boost as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for ...

The EU approval comes after Eisai and Biogen were given approval for a new once-monthly intravenous maintenance dose of ...

CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.

Johnson & Johnson (J&J) has announced that its Tremfya (guselkumab) has been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease (CD).

Eisai & Biogen announce update on regulatory review of MAA for lecanemab to treat early Alzheimer’s disease by European Commission: Tokyo Wednesday, April 16, 2025, 11:00 Hrs [I ...

Additionally, the CHMP will review the clarity of risk minimization ... with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and ...

CHMP recommends approval for Averoa’s Xoanacyl, an oral therapy for chronic kidney disease: Grenoble, France Friday, April 4, 2025, 12:00 Hrs [IST] Averoa, a biopharmaceutical c ...

The European Commission upheld CHMP's opinion, ending Translarna's ... In 2024, PTC submitted four regulatory approval applications to the FDA, all of which have been accepted for review ...