Moment Of Truth For Eight New Drugs In EU
Mix Of Novel Treatments And Generics May Get Approval Recommendation
Executive Summary
PTC Therapeutics’ gene therapy, eladocagene exuparvovec, and Sanofi’s enzyme replacement therapy, olipudase alfa, are among the latest products that the European Medicines Agency is considering for potential marketing approval.
You may also be interested in...
Marketing Firsts Due As Amryt’s Filsuvez And Roche’s Lunsumio Win EU Nod
Amryt’s epidermolysis bullosa gel and Roche’s CD20xCD3 bispecific antibody for follicular lymphoma are among four drugs that have received the thumbs up from the European Medicines Agency.
Carogra, Xenpozyme Among Japan World-First Approvals
The latest batch of new drug approvals in Japan includes several products receiving their first marketing clearances globally, notably a new oral competitor to a blockbuster ulcerative colitis drug and a high-need therapy for the rare disease ASMD.
Amryt Due For Oral Explanation At EMA For Epidermolysis Bullosa Gel Filsuvez
Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.