Keeping Track: US FDA's Late Summer Approval Extravaganza Stars Three Novel Agents, Features Return Of Mylotarg
Executive Summary
Kymriah, Vabomere, and benzidazole approvals joined by new indications for Austedo, Faslodex.
You may also be interested in...
Keeping Track: Four Novel Agents Clear US FDA, Including Evrysdi, Blenrep
The latest US FDA approvals and actions from the Pink Sheet’s US FDA Performance Tracker.
Teva Set For Immediate US Launch Of Austedo In Tardive Dyskinesia
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.
Actemra CAR-T-Related Indication Comes With Help From Novartis, Kite, US FDA
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.