Mustang Bio Joins RMAT List; Eiger Brings Home Its 4th BTD
Gene therapy and lambda interferon products are highlighted in the new Review Pathways section of the US FDA Performance Tracker, which keeps track of breakthrough therapy (BTD), regenerative medicine advanced therapy (RMAT), qualified infectious disease product (QIDP) designations and biosimilar submissions.
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Deal Snapshot: Sentynl will pay $20m in upfront and regulatory milestone payments through FDA approval, while Cyprium will retain 100% ownership of the priority review voucher.
Fresh Or Frozen? Orchard Aims For Cryopreserved Gene Therapy Approvals Using Pivotal Trials With Fresh Cell Formulations
Orchard aims to submit three ex vivo autologous gene therapies for approval by the end of 2021, helped by a new regenerative medicine advanced therapy designation (for a rare primary immunodeficiency syndrome) and a breakthrough therapy designation (for another rare primary immunodeficiency).
Four biosimilar candidates are under US FDA review, including what could be Pfizer’s eighth biologic approved under FDA’s 351(k) biologics license application pathway.