Moderna says FDA refuses its application for new mRNA flu vaccine

FDA refuses Moderna's application for new mRNA flu vaccine, company says

Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how the company conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. Its a rare move by the FDA, which is under the control of Health Secretary Robert F. Kennedy Jr.

FDA Rejects Moderna’s Experimental Flu Vaccine Over Trial Standard Concerns

The Food and Drug Administration (FDA) has denied a review to the pharmaceutical giant Moderna over its latest experimental flu vaccine.

Moderna shares fall as FDA declines to review new flu vaccine

Shares of Moderna slumped nearly nine per cent in premarket trading on Wednesday after the U.S. Food and Drug Administration declined to review the company’s application for approval of its experimental influenza vaccine, underscoring shifts in U.S. vaccine policy.

Moderna's Vaccine Ambitions Hit by FDA Roadblock

Moderna's Vaccine Ambitions Hit by FDA Roadblock Shares of Moderna plunged nearly 9% in premarket trading on Wednesday as the U.S. Food and Drug Administration decided not to review the company's application for its experimental influenza vaccine, indicating changes in U.S. vaccine policy. This setback hampers Moderna's efforts to compensate for declining COVID-19 vaccine revenue and underscores doubts about the mRNA platform's long-term potenti…