GlobalData on MSN

FDA accepts Beren Therapeutics’ NDA for Niemann-Pick disease

The submission includes data indicating a meaningful survival benefit for infantile-onset NPC patients treated with adrabetadex.
PharmiWeb

Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann-Pick Disease Type C

Accepted for priority review with Prescription Drug User Fee Act (PDUFA) action date of August 17, 2026--If approved, ...
WISH-TV

Health Spotlight | Pioneer drug stops NPC

INDIANAPOLIS (WISH) — Niemann-Pick Type C, or NPC, is a relentlessly progressive and fatal genetic disorder that impacts both the body and the brain. In the U.S., only about 900 people are living with ...
Rutland Herald

Beren, Through its Subsidiary Mandos, Submits New Drug Application to U.S. FDA for Adrabetadex in Infantile-Onset NPC

Beren Therapeutics P.B.C. ® (“Beren”) today announced that its subsidiary Mandos LLC ® (“Mandos”) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...
WNEM-TV

Pioneer Drug Stops NPC

LAKELAND, Fla. (Ivanhoe Newswire) --- Niemann-Pick Type C, or NPC is a relentlessly progressive and fatal genetic disorder that impacts both the body and the brain. In the U.S., only about 900 people ...
Times Argus

Beren, Through its Subsidiary Mandos, Submits New Drug Application to U.S. FDA for Adrabetadex in Infantile-Onset NPC | Business | timesargus.com

Beren Therapeutics P.B.C. ® (“Beren”) today announced that its subsidiary Mandos LLC ® (“Mandos”) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...