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Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Amryt’s epidermolysis bullosa gel and Roche’s CD20xCD3 bispecific antibody for follicular lymphoma are among four drugs that have received the thumbs up from the European Medicines Agency.
CEO Joe Wiley has said the backing of the EMA's advisory committee for its epidermolysis bullosa gel represents "the most significant milestone in Amryt’s history" and is a massive boost for the Dublin-headquartered group after getting a complete response letter in the US a couple of months ago.