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
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Novartis will not start to compete in the increasingly crowded US multiple sclerosis marketplace with ofatumumab this month, as regulators extend the review process for the B-cell depleting therapy until September.
The company lowered revenue guidance due to COVID-19, but announced a new brand name, Roctavian, for its hemophilia A gene therapy, which it said remains on track for FDA approval later this year.
Despite Phase III miss, Novartis is hopeful that the totality of the evidence will secure it at least a limited label expansion to a sizable but harder to treat portion of the heart failure market than Entresto already serves.