New EU Approvals
Executive Summary
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Upstaza, PTC Therapeutics’ disease-modifying gene therapy for children with the fatal, rare genetic disorder, AADC deficiency.
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New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Genmab/AbbVie’s Tepkinly, for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Europe’s Proposed Chemical Ban Could Hit Many Thousands Of Global Marketing Authorizations
Drug manufacturing in the EU would grind to a halt in under three years if a proposal to restrict per- and polyfluoroalkyl substances in the European Economic Area is implemented in its current form, says industry group EFPIA.
New EU Filings
Givinostat, Italfarmaco’s investigational treatment for Duchenne muscular dystrophy, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.