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Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.

Torres joins the medtech lobby from the FDA’s Center for Devices and Radiological Health, where she was associate director for international affairs.

The device creates lesions to disrupt nerve signals that drive mucus production.

At a House subcommittee hearing on Wednesday, lawmakers on both sides of the aisle decried the nation’s high drug costs, but Democrats argued Medicaid cuts and lapsed Affordable Care Act subsidies are worsening the problem.

Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.

The cut grants, which were viewed by Healthcare Dive, fund a wide swath of areas including workforce initiatives, STI prevention measures, health equity proposals and others in California, Colorado, Illinois and Minnesota.

The sudden departure stands in contrast to other EU pharma leaders who have been given much longer transitions in recent months, including GSK’s Emma Walmsley and Novo Nordisk’s Lars Fruergaard Jørgensen.

The oral version of Wegovy has made GLP-1 medicines more accessible and acceptable to many patients who had steered clear of injectable versions, healthcare analytics firm Truveta suggests.

AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product.

In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe and Jennifer Fakish at Danaher Corporation. They discuss how antibody drug conjugates (ADCs) are transforming cancer care. With AI-powered pathology, doctors can now measure HER2 more precisely to match patients with the best treatments.