Moderna Blames FDA for Threatening US Leadership in Medicine

Moderna Inc. lashed out at the US Food and Drug Administration for making it harder for companies to create new medicines, escalating a dispute between the vaccine maker and the regulator.

In a call with analysts on Friday, Chief Executive Officer Stephane Bancel said the agency had become unpredictable. If the FDA keeps it up, it “threatens US leadership in innovative medicines.”

The sharp comments come days after the agency refused to review Moderna’s application for a flu shot using the same mRNA technology behind its Covid vaccine. The flu vaccine is key to the company’s forecast that it will ...