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Keeping Track: Vertex’ Trikafta Speeds To US Approval; New Indications For AZ’s Farxiga, J&J’s Stelara, GSK’s Zejula

 
• By Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Trackers.

Keeping Track Feature image

Here's your US review and approval news – a little earlier this week than usual: Vertex Pharmaceuticals Inc. received the go-ahead to launch its fourth cystic fibrosis treatment this week when the FDA cleared the triple combination therapy Trikafta for a broad indication in the orphan space. Trikafta also brought the Center for Drug Evaluation and Research’s annual novel agent approval count to 33.

The Food and Drug Administration also approved new indications for AstraZeneca PLC’s Farxiga to reduce risk of hospitalization for heart failure in diabetes patients with established cardiovascular disease or...

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