National

FDA Commissioner Makary defends agency's decision on Replimune's drug

By Reuters Reuters
U.S. Food and Drug Administration Commissioner Dr. Marty Makary, speaks during a press conference as new actions on the opioid 7-OH compound are announced, at the Department of Health and Human Services in Washington, D.C., July 29, 2025. REUTERS/Jonathan Ernst
U.S. Food and Drug Administration Commissioner Dr. Marty Makary, speaks during a press conference as new actions on the opioid 7-OH compound are announced, at the Department of Health and Human Services in Washington, D.C., July 29, 2025. REUTERS/Jonathan Ernst Jonathan Ernst Reuters

May 5 (Reuters) - U.S. Food and Drug Administration Commissioner Dr. Marty Makary on Tuesday defended the agency's decision to not approve Replimune's drug for advanced skin cancer.

"If you read our what we call our complete response letter, you will see the details of the FDA logic," Makary said in an interview on CNBC.

Replimune shares were down 5% in morning trading.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)

Copyright Reuters or USA Today Network via Reuters Connect.

This story was originally published May 5, 2026 at 11:03 AM.

Get unlimited digital access
#ReadLocal

Try 1 month for $1

CLAIM OFFER