Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes
Executive Summary
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
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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.
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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.