EMA Updates Archives

Biogen’s High-Dose Nusinersen Wins CHMP Backing for Enhanced SMA Treatment

November 18, 2025 by Shajini

Biogen has earned a positive CHMP opinion for its high-dose nusinersen regimen, supported by strong DEVOTE study results showing major motor improvements and reduced mortality risk in SMA patients.

EMA, CHMP NOVEMBER 2025 MEETING: TEN NEW APPROVALS, FOUR INDICATION EXTENSIONS

November 17, 2025 by Athithi

CHMP’s November 2025 meeting delivered 10 new drug approvals, four indication extensions, and several high-profile withdrawals, highlighting continued momentum in gene therapy, oncology, immunology, and diagnostics.

EMA Links Semaglutide to Rare Vision Loss Risk

June 9, 2025 by Shajini

Two-fold increased risk prompts label updates for blockbuster GLP-1 drugs.