Keeping Track: Submissions From Sanofi, Merck, Novartis; Breakthrough Designations For GSK And Takeda

The latest news of submissions and expedited review designations from the Pink Sheet’s US FDA Performance Tracker

Earnings season brings information ranging from news tidbits, like a new brand name for BioMarin Pharmaceutical Inc.’s hemophilia gene therapy, to submissions including Sanofi’s novel biologic sutimlimab and new indications for Merck & Co. Inc.’s Keytruda and Novartis AG’s Entresto.

The ranks of breakthrough therapy designations rose by two, with BTDs announced by GlaxoSmithKline PLC (Benlysta for lupus nephritis)...

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