Search Results for keywords:"Novo Nordisk"

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Search Results: keywords:"Novo Nordisk"

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  • 2025-00750 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)
    Type:Notice
    Citation:90 FR 3880
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a priority review voucher to Novo Nordisk, Inc. for their drug ALHEMO (concizumab-mtci), which is used to reduce bleeding episodes in patients with certain types of hemophilia. This award is part of the FDA's program to encourage the development of treatments for rare pediatric diseases. The voucher is given because ALHEMO met specific criteria for applications targeting rare pediatric conditions.

    Simple Explanation

    The FDA gave a special prize, called a priority review voucher, to a company named Novo Nordisk because they made a medicine called ALHEMO that helps kids with a rare illness bleed less. This prize encourages the creation of medicines for kids with uncommon diseases.

  • 2024-30418 — Notice Pursuant to the National Cooperative Research and Production Act of 1993-Subcutaneous Drug Development & Delivery Consortium, Inc.
    Type:Notice
    Citation:89 FR 104209
    Reading Time:about a minute or two

    The Subcutaneous Drug Development & Delivery Consortium, Inc. has notified the Attorney General and the Federal Trade Commission about changes in its membership as required by law. New members of this research venture include Janssen Research & Development, LLC, Novo Nordisk from Denmark, and Ypsomed AG from Switzerland. This action is part of the ongoing compliance with the National Cooperative Research and Production Act, which limits the damages that antitrust plaintiffs can recover in certain circumstances. The Consortium plans to keep the membership open and continues to update the authorities on its developments.

    Simple Explanation

    The Subcutaneous Drug Development & Delivery Consortium has added three new members to its team and told the government about it, just like they are supposed to do, to keep everything fair and honest.