Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
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Keeping Track: US FDA Approves Zokinvy, Defers Liso-Cel, Declines ALKS 3831 And Zimhi; Two Biosimilars Filed
The latest drug developments news and highlights from the Pink Sheet’s US FDA Performance Tracker
The European Medicines Agency is this week deciding whether or not to recommend pan-EU marketing approval for Roche’s subcutaneously injected fixed-dose combination of Perjeta and Herceptin. The agency is also deciding on a marketing application for the company's flu antiviral, baloxavir marboxil.
The European Medicines Agency produces a monthly list of the marketing authorizations that are under review at the agency. The latest list contains just two new entries.