Regenerative Medicine Comes Of Age – In The Age Of COVID-19
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
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With more data reported at ASH, Vertex and CRISPR Therapeutics added heft to the notion that functional cures are on the horizon for the inherited blood disorders sickle cell disease and beta-thalassemia. Attention is now turning to Bluebird’s marketing strategy after a filing delay.
Keeping Track: US FDA Approves Zokinvy, Defers Liso-Cel, Declines ALKS 3831 And Zimhi; Two Biosimilars Filed
The latest drug developments news and highlights from the Pink Sheet’s US FDA Performance Tracker
Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.