Vinay Prasad, the U.S. Food and Drug Administration’s chief medical and science officer and director of the Center for Biologics Evaluation and Research, has left the agency after a tenure of barely three months, a Department of Health and Human Services spokesperson confirmed late Tuesday. The oncologist was appointed in May by FDA Commissioner Marty Makary with a mandate to tighten evidence standards for vaccines, cell and gene therapies. Prasad’s departure follows escalating criticism of his handling of Sarepta Therapeutics’ Elevidys gene therapy for Duchenne muscular dystrophy. The FDA last week ordered a halt to shipments after safety concerns linked to patient deaths, then reversed course two days later under intense pressure from patient groups and conservative commentator Laura Loomer, who accused Prasad of politicizing reviews. He had also imposed stricter criteria on COVID-19 vaccine approvals and rejected applications from Replimune and Capricor Therapeutics, moves that unsettled industry and some lawmakers. Analysts said Prasad’s exit reduces regulatory risk for biotech developers. Shares of Replimune surged 58 percent in pre-market trading Wednesday, while Sarepta gained about 11 percent and Capricor roughly 18 percent; the Nasdaq Biotechnology Index has recovered losses posted when Prasad was appointed. The FDA website lists recently installed drug-review chief George Tidmarsh as acting CBER director, but the agency has not indicated when a permanent successor will be named.