Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune is set to resubmit its melanoma drug for FDA approval following a leadership change at the agency. The drug had previously faced two rejections under former Commissioner Marty Makary, who recently resigned. Replimune claims to have reached an agreement with the FDA, which will prioritize the review of their application.
- ▪Replimune plans to resubmit its melanoma drug to the FDA after a leadership shakeup.
- ▪The drug was previously rejected twice under former FDA Commissioner Marty Makary.
- ▪Replimune accused the FDA of wrongfully blocking their treatment, while the FDA cited issues with clinical trial guidance.
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Replimune plans to resubmit its melanoma drug to the Food and Drug Administration for review after a leadership exodus at the agency, the company said Friday. The FDA twice rejected Replimune's melanoma treatment under the previous FDA leadership, including former Commissioner Marty Makary, who stepped down earlier this month. Replimune had accused the FDA of wrongfully blocking what some doctors see as a promising new way to treat the skin cancer, while the FDA had said Replimune ignored the agency's guidance for conducting its clinical trials.The bitter fight became a flashpoint for what some in the drug industry saw as mixed messaging from the FDA under Makary's leadership.
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