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FDA to review Moderna's mRNA flu vaccine

FDA Reverses Course on Moderna’s mRNA Flu Shot Application, Promising August Decision

The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.

· 2h · on MSN

FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine

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FDA’s abrupt flip-flop on Moderna’s mRNA flu shot highlights growing risks to drug-makers of investing in vaccines

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FDA reverses course and will review Moderna’s mRNA flu shot, company says

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday.

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FDA reverses course, will review Moderna's mRNA flu vaccine

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FDA Reverses Course and Will Now Review Moderna’s Flu Shot

Yahoo

Changing the FDA’s Vaccine Approval Process Could Threaten COVID, Flu Protection for Children

Add Yahoo as a preferred source to see more of our stories on Google. The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. The memo, which was written by FDA chief medical and scientific ...

Fierce Biotech

FDA accepts filing for Moderna flu vaccine after swift rethink

The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026-27 flu season.

Pharmaceutical Technology on MSN

FDA’s commissioner vouchers prompt questions about award process

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear.

Fierce Pharma

Senate HELP Committee chair pitches proposals for FDA reform

In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce regulatory burdens on drugmakers.