Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

Orchard Therapeutics is on the cusp of the first approval for its ex vivo gene therapy, Libmeldy, for metachromatic leukodystrophy.

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.

The sponsors of 11 new treatments should learn this week whether the European Medicines Agency will recommend EU marketing approval for their products.