October PDUFA dates feature quartet backed by EMA’s CHMP

If backing by EMA’s CHMP reads through to FDA, four of the five applications on the U.S. regulator’s docket for October are in good shape even as GSK’s Blenrep has seen its share of speed bumps in the U.S.

Among the four applications that have already received at least a positive opinion from EMA’s CHMP, two have been approved by the EC: Blenrep belantamab mafodotin from GSK plc (LSE:GSK; NYSE:GSK) for multiple myeloma, and SYD-101 from Sydnexis Inc. to treat pediatric myopia. Santen Pharmaceutical Co. Ltd. (Tokyo:4536) has rights to the latter in Europe, where the low-dose atropine is called Ryjunea...