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Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track Feature image

The US FDA’s Center for Biologics Evaluation and Research took only half of 2021 to match its novel approval count for all of 2020, issuing its fifth approval of a new biologic this year on 15 June to Mallinckrodt plc’s StrataGraft.

June has been a particularly busy month for CBER: the StrataGraft regenerative skin therapy for thermal burns is third novel biologic approved this month, following Prometic Biotherapeutics’s plasma-derived plasminogen Ryplazim

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