Keeping Track: Immunology Drives US FDA Action, With Approvals For AZ/Amgen’s Tezspire, Argenx’s Vyvgart, And New JAK Uses

Two first-in-class novel biologics cleared the US Food and Drug Administration on 17 December, bringing the annual approval count for the FDA’s Center for Drug Evaluation and Research to 48 with just two weeks left in the year.

The approvals of AstraZeneca PLC/Amgen, Inc.’s Tezspire for severe asthma and argenx N.V.’s Vyvgart in generalized myasthenia gravis capped a week dominated by the interrelated fields of...