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.

Keeping Track Feature image

FDA has been closing out the summer with a rash of approvals, including three novel agents. Novartis AG's Kymriah, the first CAR-T cell therapy, may have dominated headlines, but FDA also approved a new antibiotic (The Medicines Co.s Vabomere) and benznidazole, the first Chagas disease therapy.

FDA also cleared the return to market of Pfizer Inc.'s Mylotarg, a hematologic oncology agent that was withdrawn in 2000, and a new first-line indication for AstraZeneca PLC's...

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