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FDA Cellular, Tissue, and Gene Therapies Advisory Committee

FDA Cellular, Tissue, and Gene Therapies Advisory Committee

Federal advisory panel

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Stories

FDA weighs Replimune's melanoma immunotherapy RP1

Rule Changes

Voted July 30 on whether the data support approval

Patients with advanced melanoma that keeps growing after standard immunotherapy have almost nothing left to try. Replimune wants to sell them a virus that is injected straight into tumors. On July 30, an FDA expert panel voted on whether the company's trial data are solid enough to prove the drug works.

Updated 3 hours ago