FDA approval

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Favicon Fierce Pharma

FDA approves Denali's Hunter syndrome drug

In approving Avlayah, the FDA has greenlit the first treatment for Hunter syndrome that addresses the condition’s pernicious cognitive symptoms.
Darren Incorvaia Mar 25, 2026 2:50pm
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JenaValve secures FDA's 1st approval in aortic regurgitation

Mar 18, 2026 10:05am
Novocure TTFields

Novocure gets FDA nod for device targeting pancreatic cancer

Feb 17, 2026 4:15am
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Guardant Health gets FDA nod to expand test for colon cancer

Jan 26, 2026 8:15am
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After 20 years, Medtronic claims neurostim approval in dystonia

Dec 4, 2025 10:25am
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Ceribell nets FDA nod for detecting seizures in preterm newborns

Nov 26, 2025 9:49am