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FDA Continues To Speed PD-1/L1 Drugs To Market

 
• By Mary Jo Laffler and Bridget Silverman

The four-month review of Merck’s Keytruda for first-line lung cancer is a reminder of how quickly the agency has acted on the immune checkpoint inhibitors.

The approval of the first-line lung cancer indication for Merck & Co. Inc.’s PD-1 inhibitor Keytruda in just four months – two months before the user fee goal date – shows that FDA’s Office of Hematology and Oncology Products is still willing and able to meet its unofficial internal deadline for early action for major approvals.

With some of the most significant product reviews across the agency under its purview, OHOP set up its own internal...

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• By Eliza Slawther

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
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US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

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