Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries
Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.
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Keeping Track: Terlipressin Falls Short Of US FDA Approval; Novel NDAs From Pfizer And Apellis; New BTDs For Sanofi, BeyondSpring
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
With just 10 user fee goal dates coming up, September could be break from the fast pace of FDA decisions over the summer.
Agency has created a centralized team to help review divisions with virtual advisory committee preparations and is trying to notify sponsors earlier in the review process about the need for a panel; sponsors cite importance of having a back channel of communications so team members can communicate with each other while an AdComm is underway.