The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get lifesaving technologies to patients sooner. The program will allow for companies to obtain scientific advice from the expert panels intended to support evidence generation and clinical development of their devices.

Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.

Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy.