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 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 ...

Moderna says FDA refuses to review its application for flu vaccine

Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...
Opinion

Editorial: Letting disease win — FDA’s dangerous refusal of Moderna’s new mRNA flu vaccine

The anti-science, anti-medicine mindset of the nutso Health and Human Services Secretary Robert F. Kennedy Jr. is killing people by quashing life-saving vaccines. There is no other explanation why ...

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 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 ...

FDA Refuses to Review Moderna’s New Flu Shot

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...

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 ...
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 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 vaccine application

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.