Moderna looks outside US for growth after FDA's flu shot refusal

By Mariam Sunny and Michael Erman Feb 13 (Reuters) - Moderna said it is looking for growth overseas after the U.S. FDA ...

Wall Street eyes Moderna earnings after FDA rebuff

Moderna will report its fourth-quarter 2025 earnings this morning in an investor call that’s taken on even more interest in ...

Moderna says FDA refuses its application for new mRNA flu vaccine

Moderna received a refusal-to-file letter from the FDA objecting to how it conducted a 40,000-person trial comparing its new ...

FDA refuses Moderna’s mRNA flu vaccine application

Presented by the Coalition to Strengthen America’s Healthcare{beacon} Health Care Health Care The Big Story FDA refuses ...

FDA Refuses to Review Moderna’s New Flu Shot

The flu vaccine is its first using mRNA technology for influenza.

FDA refusing to review Moderna mRNA flu shot application

Moderna said on Tuesday that the Food and Drug Administration (FDA) has refused to review its application for an mRNA flu ...

FDA blindsides Moderna with refusal to review flu vaccine application: ‘We’re pretty confused’

The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...
Fierce Pharma

With the FDA's Moderna decision, vaccine makers face increasingly uncertain regulatory environment

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...

FDA officials defend decision to not review Moderna’s new flu vaccine

Federal officials on Wednesday cast blame on Moderna as they stood by the Food and Drug Administration’s controversial ...

FDA won’t review Moderna application for first mRNA-based flu vaccine

The decision, which shocked company officials, comes as the FDA says it will take a stricter approach to federal vaccine approvals.

FDA refuses to review Moderna's mRNA flu shot

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

FDA refuses to review Moderna’s application for mRNA flu vaccine, company says

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...