Gilead’s Long-Acting HIV Drug Among Latest EU Filings
The European Medicines Agency has added seven new products to its list of medicines that are under review for potential EU marketing authorization.
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Vutrisiran, Alnylam’s investigational RNAi therapeutic for treating hereditary transthyretin-mediated amyloidosis in adults with polyneuropathy, is among the latest new medicines that have been submitted for review for potential pan-EU approval.
The UK biotech is the first company to file a T-cell receptor therapy with regulators, a class with potential to hit targets unreachable for antibodies and CAR-Ts.
If Immuncore's tebentafusp is fast-tracked all the way through the centralized procedure at the EMA, it could be approved a few months earlier than it otherwise would be.