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

CEO of GSK Plays Down Its Role in FDA Effort

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 Walmsley described as "an administrative request" during a panel discussion at the STAT Summit.

GSK's role in the FDA's effort is limited to this administrative task, with no commercial or scientific interests involved.

Author's summary: GSK's CEO downplays company's role in FDA approval effort.

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STAT STAT — 2025-10-15

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