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FDA/Panel Decisions

Genzyme: FDA Grants Priority Review Designation To NDA For Cerdelga

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Genzyme, a Sanofi company (SNY) announced that the FDA has granted a six-month Priority Review designation to its New Drug Application for Cerdelga (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1.

The marketing applications for Cerdelga are based on two positive Phase 3 studies for eliglustat, ENGAGE, which included patients new to therapy, and ENCORE which included patients switching from enzyme replacement therapy. The submissions include four years of safety and efficacy data from the eliglustat Phase 2 study.

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Global Economics Weekly Update - April 27 – May 01, 2026

May 01, 2026 15:54 ET
Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.

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