CEPI to Fund Pivotal Phase 3 Trial for Moderna's mRNA Pandemic Influenza Vaccine Candidate

Up to $54.3 million CEPI investment aims to help advance Moderna's H5 pandemic influenza vaccine candidate to licensure ...

EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending ...

NEXSPIKE is Moderna’s third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...
Nasdaq

Moderna Announces Updated COVID-19 Vaccine Against LP.8.1 Variant Generates Strong Immune ...

CAMBRIDGE, MA / ACCESS Newswire / September 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax®, which targets the LP ...
Yahoo

What you need to know about Moderna’s new COVID vaccine, just approved by the FDA

Not all children are eligible for the new Moderna COVID shots. Moderna, over the weekend, announced that the U.S. Food and Drug Administration had approved its second-generation COVID vaccine, but ...
The Pharma Letter

CEPI to fund Moderna’s mRNA pandemic flu candidate

The USA’s Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $54.3 million to support a pivotal Phase III clinical trial that aims to help advance Moderna’s investigational ...
Nasdaq

Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at ...

CAMBRIDGE, MA / ACCESS Newswire / June 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's ...
Yahoo

FDA clears Moderna’s new COVID vaccine, but with limits

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. CHICAGO — The Food and Drug Administration has granted ...
CBS News

Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, ...
Seeking Alpha

Moderna: Can They Benefit From Bird Flu? (Rating Upgrade)

Moderna's stock is down 36.63% due to poor COVID-19 vaccine sales and lack of promising alternatives, but bird flu presents asymmetric upside potential. The company's cost-cutting measures may hinder ...
U.S. News & World Report

Moderna Norovirus Vaccine Trial on Hold by US FDA Over Neurological Side Effect

(Reuters) -Moderna said on Friday that the U.S. FDA paused a late-stage trial of its experimental norovirus vaccine after a case of a rare neurological side effect was reported. The trial of the ...

FDA intends to put its most serious warning on Covid vaccines, sources say

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

Down 80%, Should You Buy the Dip on Moderna?

Since that moment, Moderna has taken steps to pave the path to long-term growth -- from cutting costs to focusing on its vast ...