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  • Drug Approvals and Databases | FDA
    Downloadable data files FDA Adverse Event Reporting System (FAERS) Public Dashboard Inactive Ingredient Search for Approved Drug Products Search More information Medication Guides Search More
  • FDA-Approved Treatments for Alzheimers
    FDA-Approved Drugs For Alzheimer's The FDA has approved medications that fall into two categories: drugs that change disease progression in people living with early Alzheimer's disease, and drugs that may temporarily mitigate some symptoms of Alzheimer's dementia
  • 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
  • FDA approves Denalis Hunter syndrome drug
    The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates In approving
  • UPLIZNA® (INEBILIZUMAB-CDON) IS NOW THE FIRST AND ONLY FDA . . .
    "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
  • FDA approves Wellcovorin for ultra-rare disease. The Trump . . .
    The Food and Drug Administration (FDA) on Tuesday granted expanded approval to Wellcovorin for the ultra-rare disease cerebral folate deficiency (CFD) in both children and adults, the same
  • Denali Delivers ‘Welcome Positive’ for Rare Disease Space . . .
    The FDA has granted accelerated approval to Denali Therapeutics’ enzyme replacement therapy for Hunter syndrome, handing a much-needed win to the rare disease market The drug will carry the brand name Avlayah Wednesday’s approval for Avlayah delivers several firsts for the industry The therapy is the first new medicine for Hunter syndrome in nearly 20 years, Denali said in its press
  • FDA Approves Semaglutide to Reduce Risk of Kidney Disease . . .
    Semaglutide, marketed as Ozempic, recently became the first glucagon-like peptide 1 (GLP-1) receptor agonist approved by the US Food and Drug Administration (FDA) to reduce the risk of worsening kidney disease, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes
  • AASLD Applauds FDA Approval of First GLP-1 Therapy for MASH . . .
    The FDA’s decision to approve Wegovy provides clinicians with a long-awaited new therapeutic option for MASH, which according to the FDA, affects about 6% of adults, or nearly 15 million people The recent FDA approval of Wegovyw for MASH follows last year’s approval of Rezdiffra (resmetirom), the first drug to treat patients with the disease
  • FDA Approval for Denali Therapeutics Blazes a New Trail for . . .
    The FDA approval announced Wednesday covers the treatment of neurologic manifestations of Hunter syndrome in pediatric patients weighing at least 5 kg (about 11 pounds) before their disease





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