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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.

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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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EU CHMP Opinions And MAA Updates

 
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