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

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

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The US FDA’s approval of Ferring Pharmaceuticals’ bladder cancer gene therapy Adstiladrin just two weeks after the company took home an approval for the pioneering microbiome therapeutic Rebyota reshaped the Center for Biologics Evaluation and Research’s list of 2022 novel approvals by putting Switzerland-based Ferring on par with bluebird bio. The companies each received two novel approvals apiece.

Gene therapies stand as the dominant theme among CBER’s eight novel approvals in 2022 to date: Ferring’s Adstiladrin brings the...

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Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.