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'Living' History: Breakthrough CAR-T Application Breaks Through In National Media

 
• By Michael McCaughan

FDA advisory committee meetings aren’t often front page news. But the Oncologic Drugs Advisory Committee review of the first CAR-T therapy was on the front page of both the Washington Post and the New York Times. Both headlines describe it as a “living drug.”

In the era of Twitter, YouTube and Facebook, making the front page of the Washington Post or the New York Times doesn’t mean as much as it once did.

But it still rare and remarkable that an FDA advisory committee meeting would be covered on the front page of...

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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

More from Regulatory Trackers

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

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.