CEO of GSK plays down its role in FDA effort to approve therapy for autism-related condition

GSK's Role in FDA Effort to Approve Therapy for Autism-Related Condition

The CEO of GSK, Emma Walmsley, stated that the company has had a minimal role in the FDA's effort to approve a long-shelved drug for a condition associated with autism.

"We have no commercial interest, we have no scientific research, and we're not pursuing it. So it's just the administration at this stage."

The FDA requested that GSK update the prescribing information for its decades-old therapy leucovorin, which the CEO described as "an administrative request".

GSK is not actively pursuing the approval of leucovorin for the treatment of the autism-related condition.

Author's summary: GSK plays down its role in FDA effort.

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STAT STAT — 2025-10-15

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