Pharmaceutical Executive Daily: September 23, 2025

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, we cover GSK’s supplemental application to update the label for Leucovorin, the FDA’s complete response letter to Otsuka and Lundbeck’s sNDA for Rexulti, and the medical community’s response to former President Trump’s claims linking Tylenol use to autism risk.

GSK has submitted a supplemental new drug application seeking to update the label for Leucovorin, a long-standing therapy used in combination with chemotherapy and to counteract toxic effects of certain drugs. The update reflects new clinical data and is aimed at ensuring prescribers and patients have access to the most current safety and efficacy information. While leucovorin has been on the market for decades, label updates like this underscore how manufacturers continue to refine established therapies to support safe and effective use in oncology and other treatment settings.

Meanwhile, the FDA has issued a complete response letter to Otsuka and Lundbeck regarding their supplemental application for Rexulti. The companies had sought approval for expanded use of the therapy, but the FDA cited the need for additional data before a decision can be made. Rexulti is already approved for schizophrenia and adjunctive treatment of major depressive disorder, and the rejection represents a setback as the companies attempt to broaden its commercial reach. Analysts expect Otsuka and Lundbeck will revisit trial design and regulatory strategy as they weigh next steps.

And finally, former President Donald Trump has claimed that prenatal use of Tylenol may increase the risk of autism, drawing sharp criticism from the medical community. Physicians and researchers pushed back strongly, emphasizing that existing evidence does not support the assertion and warning that such statements could discourage safe use of one of the most widely relied-upon medications in pregnancy. Experts stressed the importance of basing public health guidance on rigorous data, particularly in a politically charged environment where misinformation can spread quickly.

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