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J&J's Tecvayli claims third national priority FDA approval

J&J claims the FDA's third national priority voucher approval, advancing a Tecvayli-based regimen for multiple myeloma into the second-line setting.

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Hansa closes on FDA verdict for transplant drug imlifidase

The FDA has started reviewing Hansa's imlifidase for highly sensitised adults needing a kidney transplant, but not in the requested rapid timeframe.

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Ascendis scores FDA approval for weekly dwarfism drug

Children with achondroplasia will soon have the option of a once-weekly - rather than daily - injection, courtesy of Ascendis' newly approved Yuviwel.

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CMS extends deadline for MFN pricing pilot scheme

CMS has extended the deadline for its Medicaid drug pricing pilot, GENEROUS, to "provide interested drug manufacturers more opportunity to join."

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New FDA knockback hits uniQure and Huntington patients hard

uniQure looks like it may have to run another trial of its Huntington's disease gene therapy AMT-130, delaying the highly anticipated programme.

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CHMP backs Ipsen drug for childhood brain cancer

Ipsen's Ojemda is on course to become the first targeted medicine in the EU for some children with a form of brain cancer known as low-grade glioma.

J&J's Tecvayli claims third national priority FDA approval

Hansa closes on FDA verdict for transplant drug imlifidase

Ascendis scores FDA approval for weekly dwarfism drug

CMS extends deadline for MFN pricing pilot scheme

New FDA knockback hits uniQure and Huntington patients hard

CHMP backs Ipsen drug for childhood brain cancer

Recordati gets €10.9bn takeover bid from private equity firm

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