Gene therapy for hemophilia A patients in the U.S. will have to wait. The FDA needs more time to review data from BioMarin Pharmaceuticals, and the agency told the company it won’t be able…
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Late last year, the Department of Justice (DOJ) made revisions to its corporate criminal enforcement policies that provide useful insights to corporations and their executives regarding establishing policies and procedures to mitigate criminal liability exposure….
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As healthcare organizations continue to battle major workforce shortages, many are turning to labor from staffing agencies. But before healthcare providers onboard workers sourced from these agencies, they should make sure these laborers are…
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There have been numerous industry complaints – and a number of lawsuits – about the Centers for Medicare & Medicaid Services’ (CMS) rollout of the No Surprises Act (NSA). Nevertheless, CMS and the other…
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The FDA has accepted Eisai’s application seeking full approval for its Alzheimer’s disease drug, setting a summer date for a regulatory decision that could smooth the path for insurance companies to begin coverage for…
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On April 1, the regular renewal process for Medicaid will return. But after about three years of not having to renew coverage, 64.3% of Americans are unaware that redeterminations will start up again, a…
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The seismic crumbling of U.S. federal abortion protection shocked the nation last summer. From wide ranging personal responses to corporate promises of abortion assistance, the landscape for reproductive health is experiencing unprecedented change. Evolving…
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Pharmacy benefit managers (PBMs) are being targeted yet again by the government. James Comer (R-Ky), House Committee on Oversight and Accountability chairman, launched an investigation Wednesday into PBMs and their “tactics that are harming…
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Happy Friday everyone! Yesterday I tweeted that to someone and then realized it was only Thursday and not Friday which probably says a little bit about how the week has gone for me. Time…
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The Federal Trade Commission has started cracking down on digital health companies for allegedly sharing consumers’ health data for advertising purposes. Last month, the agency said GoodRx had shared personal health information with third parties…
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