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  • Denali Therapeutics Announces U. S. FDA Approval of AVLAYAH . . .
    First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage disease First FDA-approved medicine in emerging new class of biotherapeutics that leverage transferrin receptor to cross blood-brain barrier Denali’s first medicine enabled by its TransportVehicle™ platform designed to deliver biotherapeutics to whole body, including brain Rare
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    Drugs marked "unapproved medical gas", "unapproved homeopathic" or "unapproved drug other" on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved In addition, FDA is not aware of scientific evidence to support homeopathy as effective
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    This page searches the Orphan Drug Product designation database Searches may be run by entering the product name, orphan designation, and dates Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet Click for detailed instructions
  • Denali Therapeutics Receives FDA Approval for AVLAYAH™, First . . .
    Potential Positives FDA approval of AVLAYAH™ represents the first new treatment option for Hunter syndrome in nearly 20 years, providing renewed hope for patients and families AVLAYAH is the first FDA-approved therapy designed to cross the blood-brain barrier, showcasing innovative advancements in biotherapeutics Denali Therapeutics received a Rare Pediatric Disease Priority Review Voucher
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    "The FDA approval of UPLIZNA marks a significant turning point for IgG4-RD patients and physicians who now have a proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use," said Jay Bradner, M D , executive vice president of Research and Development at Amgen





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