FDA Begins Review of uniQure Gene Therapy Candidate for Huntington’s Disease

As reported by the Manila Times, the FDA has formally accepted uniQure’s biologics license application for ifezuntirgene inilparvovec (AMT-130), an experimental gene therapy being developed for people living with Huntington’s…

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FDA Review Raises Questions About Replimune’s Melanoma Therapy Ahead of Advisory Committee Vote

As reported on Reuters, Replimune’s experimental cancer treatment RP1 is facing increased regulatory scrutiny after U.S. Food and Drug Administration (FDA) reviewers expressed concerns about whether current clinical data adequately…

Continue Reading FDA Review Raises Questions About Replimune’s Melanoma Therapy Ahead of Advisory Committee Vote