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Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for BRIMOCHOL™ PF for the Treatment of Presbyopia
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4 Articles
FDA Accepts Tenpoint's New Drug Application for Brimochol PF for the Treatment of Presbyopia
Tenpoint Therapeutics announced that the 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. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application. “This milestone marks a significant step forward in our transition toward becoming a commercial-stage company, and we look…
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