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Keeping Track: US FDA Oncology Approvals For Ferring’s Gene Therapy Adstiladrin And Mirati’s Targeted Therapy Krazati

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Mirati’s Krazati Is Second KRAS Inhibitor To Market, But At Higher Price

Krazati was approved for second-line NSCLC with labeling that positions it ahead of Lumakras on efficacy, but not safety. Pricing is slightly higher than for Amgen’s drug.

How The Curtain Finally Closed On Ferring/Blackstone’s Gene Therapy Venture FerGene

Having failed to live up to its promising beginnings, FerGene, the gene therapy firm founded with the backing of Ferring and Blackstone to advance the former’s candidate for bladder cancer is back under the Swiss pharma's wing. However, doubts about its future and that of nadofaragene firadonavec remain.

End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes

Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

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