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Latest From Bridget Silverman
Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.
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.
US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.
Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD
The latest drug development news and highlights from our US FDA Performance Tracker.
The past three years have seen an increase in number of orphan drug labels containing appropriate pediatric information.