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Public Criticism
Major editorials highlight the FDA's 'erratic' behavior as a threat to the broader innovation ecosystem.
Refusal to File
Senior regulator Vinay Prasad refuses to review Moderna's flu vaccine application, citing trial design concerns.
Grants Rescinded
The administration pulls back hundreds of millions in funding for mRNA-based research projects.
Trial Design Support
FDA officials reportedly signal support for Moderna's flu vaccine trial workaround and data submission plan.
Peak Valuation
Moderna reaches a market capitalization of $200 billion during the height of pandemic vaccine distribution.
The FDA's recent refusal to review Moderna's flu vaccine application marks a significant pivot in the regulatory environment for mRNA technology. This shift, characterized by increasing political pressure and unpredictable oversight, threatens to stifle the very innovation that defined the pandemic response.