Keeping Track: US FDA's Late Summer Approval Extravaganza Stars Three Novel Agents, Features Return Of Mylotarg
Kymriah, Vabomere, and benzidazole approvals joined by new indications for Austedo, Faslodex.
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The latest US FDA approvals and actions from the Pink Sheet’s US FDA Performance Tracker.
FDA-approved labeling includes boxed warning for depression and suicidality, though this is specific for Huntington's disease patients, who are prone to these conditions.
Genentech's interleukin-6 inhibitor got bonus approval based on data from development programs for Novartis' and Kite's chimeric antigen receptor T-cell therapies; CAR-T developers allowed FDA to access the Actemra-related data in their applications and conduct its own pooled analysis.