Advanced Therapies From Orchard & Kite Win EMA Thumbs Up
Novartis’s siRNA for lowering cholesterol was also among the 10 new medicines that the European Medicines Agency this week said should be approved in the EU.
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Alzheimer’s Drug & Dermatitis JAK inhibitor Among New EU Filings
Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.
European CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Danon Disease Gene Therapy & TGCT Treatment Win EMA PRIME Designations
Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.