Replimune secures FDA accelerated approval for melanoma therapy after two prior rejections

Replimune, a biotech based in Massachusetts, has received accelerated approval from the U.S. Food and Drug Administration for its melanoma drug. The approval comes after the therapy was rejected twice by the agency.

The company's path to approval was marked by a public clash with former FDA leaders over the drug's data and regulatory handling. The dispute highlighted differing views on the therapy's clinical benefits.

In the weeks before the decision, Replimune held a closed-door meeting with White House officials, a step that preceded the FDA's final determination.