FDA panel gives a thumbs up to Amgen’s T-Vec for melanoma

John Carroll

Amgen's regulatory team for talimogene laherparepvec (T-Vec) was grilled by a group of outside FDA experts who picked up on some major questions regarding the Phase III study that was used to back its new drug application. A vigorous defense of the drug, though, helped make a winning case for the therapy, which was ultimately supported by all but one member of the .

FierceBiotech News

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