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

Eli Lilly, which is seeking European approval of Kisunla for the treatment of early symptomatic Alzheimer's, said it will seek re-examination by CHMP. The Indianapolis drugmaker said it remains ...

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

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

If the EMA follows the CHMP’s advice, Zynquista will become the second SGLT-acting drug to be approved for use alongside insulin in type 1 diabetes after AstraZeneca’s SGLT2 inhibitor Forxiga ...

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 ...

Halozyme Therapeutics (HALO) announced that Bristol Myers Squibb (BMY) received a positive opinion from the Committee for Medicinal Products ...

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