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INFECTIOUSDISEASE Heatmap

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FDA refuses to review Moderna mRNA flu vaccine application

Moderna’s mRNA flu vaccine application has been rejected by the FDA—Moderna received a refusal‐to‐file letter while accusing the agency of shifting its review standards. Multiple reports echo this regulatory setback, fueling industry concerns over consistent, transparent decision‐making. More...

FDA CRL halts AstraZeneca’s Saphnelo prefilled pen approval

AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market. More...

CMS proposes sweeping changes to ACA marketplace plan rules

CMS has proposed a major rule reshaping Affordable Care Act marketplace policies, including loosening limits on non-standard plan designs and promoting lower-premium options such as catastrophic coverage. The agency says the changes will reduce costs and boost flexibility, while critics warn they could increase confusion and weaken consumer protections—because shopping for insurance clearly wasn’t complicated enough. More...

Tenet forecasts major ACA exchange enrollment drop and financial hit

Tenet Healthcare is warning that the expiration of enhanced Affordable Care Act premium tax credits will drive a steep reduction in ACA exchange enrollment, projecting a significant revenue impact in 2026. Despite the headwind, the company says it expects earnings growth, leaning on acuity and operational performance—because nothing calms Wall Street like “we’ll make it up somewhere else.” More...

City of Hope promotes Nisha Morris to senior marketing chief

City of Hope named Nisha Morris as Senior Vice President and Chief Marketing and Communications Officer, adding marketing leadership to its executive team. The move signals a renewed focus on brand, outreach, and patient engagement as the cancer center sharpens its communication and growth strategies. More...