September saw several notable “firsts” in the regulatory landscape alongside the approval of four novel drugs in the U.S. Among these advancements, two new drugs to treat Niemann-Pick Disease, Type C, a rare genetic disease that results in progressive neurological symptoms and organ dysfunction, were approved by the FDA – IntraBio’s Aqneursa and Zevra Therapeutics’ Miplyffa. Additionally, the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used…
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Source: https://www.rttnews.com/3478262/biotech-stocks-facing-fda-decision-in-october-2024.aspx