Gather your friends and family and join is for another invigorating 2-mile walk with beautiful views of Long Island Sound around Tod’s Point in Old Greenwich, and help us raise much needed funds to find a cure for Niemann-Pick type C disease. No beach pass, no problem. DART has you covered! The morning always makes …
IntraBio files New Drug Application for N-acetyl-L-leucine (IB1001) for the treatment of NPC
IntraBio Inc. is pleased to share that the New Drug Application (NDA) for N-acetyl-L-leucine (IB1001) for the treatment of Niemann-Pick disease type C (NPC) was submitted to the US Food and DrugAdministration (FDA) in January 2024. The FDA has a 60-day filing review period to determine whetherthe NDA is complete and accepted for review. With …
Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the FDA
December 27, 2023 at 7:30 AM EST CELEBRATION, Fla., Dec. 27, 2023 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (NDA) for arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC) to the U.S. Food and Drug Administration (FDA) on December 22, 2023. Based …