Replimune to resubmit melanoma drug for FDA approval after agency leadership changes

Replimune plans to resubmit its melanoma drug to the Food and Drug Administration for review after a leadership exodus at the agency

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

The FDA had said Replimune ignored the agency's guidance for conducting its clinical trials

The bitter fight became a flashpoint for what some drugmakers had criticized as inconsistent guidance around trials and approvals