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Novartis CAR-T Therapy's Swift Approval Aided By REMS And New US FDA Review Model

 
• By Brenda Sandburg

Risk Evaluation and Mitigation Strategy for Kymriah requires the acute lymphoblastic leukemia treatment be administered by certified centers, while a postmarketing study will assess safety over 15 years. FDA's early approval reflects efforts by the biologics center and new cross-cutting Oncology Center for Excellence to implement a more collaborative review model.

Decorin protein

FDA's swift approval of Novartis AG's chimeric antigen receptor T-cell therapy Kymriah (tisagenlecleucel) was aided by the company's Risk Evaluation and Mitigation Strategy (REMS), which requires hospitals dispensing the treatment to be certified.

FDA approved Kymriah, the first gene therapy to clear the agency, on Aug. 30 for the treatment of patients up...

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A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 
• By Michael McCaughan

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PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

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