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486,364 Results for "moderna inc".
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Approvals
Moderna’s flu shot crosses FDA finish line, bouncing back from regulatory roadblock
The FDA in February slapped Moderna’s vaccine with a refusal-to-file letter—though the agency backtracked a few days later and accepted a revised submission for review. An advisory committee in June unanimously backed mFLUVISA’s approval.
August 6, 2026
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2 min read
·
Tristan Manalac
Earnings
Moderna maintains 10% growth target despite Phase 3 norovirus miss
Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.
July 31, 2026
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4 min read
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Gabrielle Masson
Adcomms
Moderna’s mRNA flu shot wins unanimous support at FDA adcomm in rebuke of former leadership
The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.
June 19, 2026
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2 min read
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Tristan Manalac
mRNA
ASCO: Moderna’s mRNA-based melanoma vaccine shows ‘encouraging’ 5-year survival
When used alongside Merck’s Keytruda, Moderna’s personalized cancer vaccine halved the risk of death or disease recurrence in a mid-stage trial of advanced melanoma—a result analysts said could help “instill confidence” in the regimen.
June 2, 2026
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2 min read
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Tristan Manalac
Adcomms
Moderna’s once-rebuffed mRNA flu shot to face scrutiny from FDA adcomm
After getting slapped with a surprise refuse-to-file letter signed by former CBER Director Vinay Prasad, Moderna’s flu vaccine application will now go before the FDA’s Vaccine advisory committee.
May 22, 2026
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2 min read
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Tristan Manalac
Podcast
Moderna’s FDA adcomm, IPO mania, biopharma layoffs, more
Moderna appears to have aligned with the FDA ahead of an advisory committee meeting for its mRNA-based flu vaccine, which the regulator initially turned away in February; biotech IPOs are going gangbusters, including two new records raises in as many weeks; layoffs continue across biopharma; plus much more.
June 17, 2026
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2 min read
·
Jef Akst
Vaccines
FDA, Moderna appear aligned on mRNA flu shot heading into adcomm
The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.
June 16, 2026
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3 min read
·
Annalee Armstrong
Vaccines
Moderna’s stock rides hantavirus fears as spotlight returns to infectious disease platform
While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
May 20, 2026
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4 min read
·
Nick Paul Taylor
Press Releases
Moderna Announces Initiation of Phase 1 Clinical Trial of mRNA-1469, Moderna’s Investigational Vaccine Against Bundibugyo Ebolavirus
August 4, 2026
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5 min read
Manufacturing
Moderna mulls deals to rescue German BioNTech plants from closure: report
The takeovers depend on Moderna reaching an agreement with the German government, which risks losing investment from drugmakers over planned healthcare reforms.
June 18, 2026
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2 min read
·
Nick Paul Taylor
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