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Bristol-Myers Squibb Says Its Supplemental Application for Psoriatic Arthritis Treatment Accepted for Review
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Bristol-Myers Squibb Says Its Supplemental Application for Psoriatic Arthritis Treatment Accepted for Review
Jul 21, 2025 4:39 AM

07:28 AM EDT, 07/21/2025 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Monday its supplemental new drug application for Sotyktu, which is for the treatment of adults with psoriatic arthritis, has been accepted for review by the US Food and Drug Administration.

The agency has assigned a Prescription Drug User Fee Act goal date of March 6, 2026, the company said.

The supplemental new drug applications for the drug has also been accepted by the China's Center for Drug Evaluation of National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare, while the European Medicines Agency has validated the company's Type II variation application to expand the drug's indication to include the disease, according to a statement.

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