Products For Cystic Fibrosis, VWD & Schizophrenia Nearing End Of EU Review
Executive Summary
The European Medicines Agency's CHMP is expected this week to adopt Lists of Outstanding Issues on products for von Willebrand disease, cystic fibrosis and schizophrenia.
You may also be interested in...
A Massive First For EU – CAR-T Therapies Kymriah and Yescarta Hoping For CHMP OK
Six orphan drugs – including the first two CAR-T cell therapies in the EU – may get the green light from the European Medicines Agency at its June meeting this week. Will the negative opinion handed down earlier this year on Puma Biotechnology’s Nerlynx be overturned, though?
EU Green Light In Sight For Aimovig; 12 Drugs In Line For Potential CHMP Decision
The European Medicines Agency's drug evaluation committee, the CHMP, will this week decide whether up to a dozen products that have been through the evaluation process should be recommended for approval in throughout the EU.
Keeping Track: Vitaros Reenters The Wilderness, Remoxy Gives It A Fourth Try, And Two Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.