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Application Refusal
FDA senior regulator Vinay Prasad issues a formal refusal to review the flu vaccine application.
Grants Rescinded
White House rescinds hundreds of millions in mRNA research grants by year-end.
Workaround Supported
Regulators appear to support Moderna's plan to use data from a smaller trial to address dosage concerns.
Collaboration Begins
FDA begins working closely with Moderna on its flu vaccine trial design.
Moderna faces a significant regulatory setback as the FDA refuses to review its new flu vaccine, citing trial design flaws despite previous guidance. This shift reflects a broader, politically charged environment that threatens to destabilize the venture-backed biotech ecosystem.