FDA granted accelerated approval Thursday (Aug. 5) of Replimune’s gene therapy for advanced melanoma, a major reversal for a drug that was rejected by the agency twice, with a third rejection ...

After FDA approval of RP1 plus nivolumab, melanoma specialists now look toward preparing for clinical use and consider the future of intratumoral therapy trials. The decision followed the July 30, ...

Kevin Harrington, Professor in Biological Cancer Therapies at Institute of Cancer Research, shared on LinkedIn: “In addition to my earlier re-posting of the FDA announcement of the approval of ...

Three submissions, two rejections, one public fight with the FDA, and, finally, an approval. On August 6, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tudriqev ...

Good news strikes from an unlikely source. On Thursday the Food and Drug Administration approved Replimune’s immunotherapy for metastatic melanoma, a day after it green-lighted mFlusiva, Moderna’s ...

Replimune can fi­nal­ly feel a sense of vin­di­ca­tion. Af­ter two re­jec­tions, pub­lic clash­ing with the pre­vi­ous FDA lead­ers and a closed-door meet­ing with the White House, the ...

Aug 6 (Reuters) - The U.S. Food and Drug Administration has approved Replimune's (REPL.O), opens new tab drug for a difficult-to-treat form of skin cancer, the company said on Thursday, giving the ...

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The ...

The Food and Drug Administration on Thursday approved a Replimune treatment for advanced melanoma, ending a saga that saw the medicine rejected twice before physicians, patients and agency advisers ...

In a remarkable turnaround, Replimune has reversed the fortune of its melanoma therapy, winning FDA approval after two prior rejections and agency leadership shakeups. Thursday, the FDA granted ...