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FDA · United StatesThe FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the treatment of advanced melanoma.According to a company press release, the letter indicates that the FDA cannot approve the application for vusolimogene oderparepvec (RP1) — the company’s leadSee the Story
FDA Rejects RP1 for Advanced Melanoma, Says IGNYTE Not a ‘Well-Controlled’ Trial
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