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FDA Eyes June AI Rollout, Misses GSK Drug Deadline, as AstraZeneca Sees Imfinzi Success
The Food and Drug Administration (FDA) is aiming for a June rollout of generative AI, while also experiencing delays in key drug approval decisions. Several biopharmaceutical companies are responding to market volatility with staff reductions. AstraZeneca (AZ) anticipates expanding the use of Imfinzi following positive trial results in bladder cancer treatment. Specifically, FDA chief Martin Makary set a June deadline for the implementation of generative AI technologies within the agency. Concurrently, the FDA missed its target date for approving GlaxoSmithKline’s (GSK) Nucala for use in treating Chronic Obstructive Pulmonary Disease (COPD). In other industry news, four additional biotech companies announced staff cuts amidst ongoing market challenges. Conversely, AstraZeneca reported successful trial outcomes for Imfinzi in bladder cancer, potentially leading to broader applications of the drug.
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Date: May 9, 2025
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