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BioWorld - Wednesday, April 22, 2026

U.S.

Home » Topics » North America » U.S.
  • Generic injection pens
    April 22, 2026
    By Mari Serebrov

    CMS to Bridge coverage for obesity drugs as BALANCE teeters

    When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but extend its temporary Medicare GLP-1 Bridge demonstration model through the end of 2027. (The Medicaid BALANCE model will still kick in this year in states that choose to participate in it.)
  • Targeted cancer cell
    April 22, 2026
    By Jennifer Boggs

    Revolution rocks on with first-line PDAC data at AACR

    And the positive news continues to flow for Revolution Medicines Inc. On the heels of a successful phase III trial for RAS inhibitor daraxonrasib in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC) – not to mention the firm pricing the largest follow-on offering in biopharma history – Revolution presented updated phase I/II data at the American Association for Cancer Research (AACR) meeting detailing impressive findings in first-line PDAC patients.
  • Woman stretching her arms and hands
    April 22, 2026
    By Randy Osborne

    Walking the talk, Kyverna phase II stiffens miv-cel CAR T case

    Optimism rose for what could be the first CAR T therapy in autoimmune disease as Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome. Kyverna plans to submit a BLA to the U.S. FDA in the first half of this year.
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Blog Posts

  • Health care politics illustration
    Aug. 26, 2020
    By Mari Serebrov

    U.S. politicking threatens public trust in the FDA and CDC

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