Tenpoint Therapeutics Ltd. announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for Brimochol PF for the treatment of presbyopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026, for the drug. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application, according to the company.
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FDA Accepts NDA for Tenpoint's Brimochol PF for the Treatment of Presbyopia
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026, for the drug.
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June 8, 2025