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Beren Therapeutics Announces FDA Extension of Review Period for New Drug Application (NDA) for Adrabetadex for the Treatment of Infantile-Onset Niemann-Pick Disease, Type C
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Beren Therapeutics Announces FDA Extension of Review Period for New Drug Application (NDA) for Adrabetadex for the Treatment of Infantile-Onset Niemann-Pick Disease, Type C
New PDUFA target action date of November 17, 2026 allows FDA additional time to complete its reviewTHOUSAND OAKS, Calif.--(BUSINESS WIRE)--Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline more... The post Beren Therapeutics Announces FDA Exten…
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