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Yervoy Survival Data From First-Line Study Sealed The Deal For FDA Approval

 
• By Sue Sutter

FDA’s approval of Bristol-Myers Squibb’s metastatic melanoma immunotherapy was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.

FDA’s approval of Bristol-Myers Squibb Co.'s metastatic melanoma immunotherapy Yervoy (ipilimumab) was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.

Faced with an application for a second-line indication and a single study showing a survival benefit, but with only modest...

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More from Approval Standards

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

Generic Drug Office’s Policy Staff Returning To US FDA

 
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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

More from Pathways & Standards

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
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The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.