Replimune to resubmit twice-rejected drug for approval after FDA shakeup

Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.

Replimune surges on plans to resubmit lead drug for FDA review

Replimune (REPL) shares climbed more than 60% in the premarket on Friday after the company announced plans to resubmit a marketing application for its lead asset RP1 in the U.S., following its second ...

CORT to Resubmit NDA for Relacorilant in Cushing's Syndrome, Stock Up

Corcept stock jumps after the company announces plans to resubmit relacorilant's NDA for treating Cushing's syndrome.

Corcept to Resubmit its New Drug Application for Relacorilant as a Treatment for Patients with Cushing’s Syndrome

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of ...

Replimune gets third chance at US approval for skin cancer drug

Replimune said on Friday it plans to resubmit the application for its experimental skin cancer drug in the coming days after reaching an agreement with the U.S. FDA, which ​previously declined to ...