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Adcomm backs Replimune melanoma drug, despite data concern
Replimune's RP1 immunotherapy for melanoma clears advisory committee vote by 10 to three, despite FDA concerns about the design of the IGNYTE study.
Market Access
Policy in Focus: What’s new with CMS drug price negotiation,...
Hogan Lovells partner Alice Valder Curran returned to elucidate some of the finer points of the latest communication from CMS.
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Cytokinetics' cardiomyopathy drug cleared for NHS use
Cytokinetics gets simultaneous MHRA and NICE approvals for hypertrophic cardiomyopathy (HCM) therapy Myqorzo.
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Lawmakers seek answers from RFK on Gardasil shot settlement
Four Democratic senators are investigating whether the family of HHS Secretary RFK Jr is profiting from what they assert are "bogus" vaccine lawsuits.
News
FDA advisors vote no to Capricor's DMD therapy
FDA advisors voted that Capricor has not shown efficacy for deramiocel in Duchenne muscular dystrophy, due to altered endpoints in its main trial.
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