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Keeping Track: Intercept Submits OCA For NASH; Zogenix’ Fintepla Returns; US FDA Approves Bavarian Nordic Vaccine

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker

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Monkeypox: Bavarian Nordic’s Jynneos Vaccine Should Be Given Only As A Two-Dose Series, US FDA Says

Despite limited vaccine supplies and a growing number of cases, public health officials nix the idea of giving only one dose of Jynneos to individuals exposed or at high risk, saying that two doses one month apart are required for full protection; FDA says it is working to expedite the availability by late July of an additional 786,000 doses made in Denmark.

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Despite positive Phase III results in Lennox-Gastaut syndrome, the effect of the company’s low-dose fenfluramine on serious seizures may not be as good as seen with GW Pharma’s Epidiolex. 

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