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).
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CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.
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.
The latest drug development news and highlights from our US FDA Performance Tracker.