On the heels of a Type A meeting with FDA’s Center for Biologics and Research (CBER), Moderna’s seasonal influenza vaccine ...
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Why did Moderna stock tumble nearly 10% after hours today?
The regulator said the Phase 3 study comparator did not reflect the “best-available standard of care,” though it raised no safety or efficacy concerns. ・Moderna said the refusal conflicts with prior ...
A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...
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