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FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

The US FDA has rejected Regeneron Pharmaceuticals’ application to manufacture its multiple myeloma drug candidate linvoseltamab, citing unresolved issues with its third-party manufacturer. While a reinspection is expected in the coming months, Regeneron said European Medicines Agency review of the drug is still ongoing. The medication is designed to treat multiple myeloma that has advanced after at least three earlier lines of therapy.

Source: medcitynews.com –

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