NewsDialy
A cancer treatment rejected twice by federal regulators has now won approval.
The Food and Drug Administration granted accelerated approval to Tudriqev, a drug made by the biotech company Replimune, for patients with advanced melanoma.
Accelerated approval is a regulatory pathway that lets the FDA greenlight a drug before long-term survival data is confirmed, on the condition that early efficacy signals are strong and patients lack good alternatives.
A troubled path to clearance The drug, known in clinical development as RP1, had a difficult history with the FDA. Two prior applications were rejected.
Keep reading