New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add five new products, including VLA2001, Valneva’s vaccine for COVID-19.
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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.
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.
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.