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Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval

 
• By Bridget Silverman

Keeping track of US FDA approvals last week included watching the creative and the familiar.

Keeping Track Feature image

FDA approvals in the past week ranged from the familiar – Merck & Co. Inc.'s Keytruda became the fifth immuno-oncology (IO) agent approved for bladder cancer – to the creative, as FDA used laboratory data to expand the indication for Vertex Pharmaceuticals Inc.'s cystic fibrosis drug Kalydeco to new gene mutations.

FDA also added data from a failed mortality trial to the labeling of GlaxoSmithKline PLC's respiratory drug Breo and...

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