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731,562 Results for "moderna inc".
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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
·
2 min read
·
Tristan Manalac
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
Earnings
Moderna beats revenue expectations with $389M, but litigation dogs earnings
CEO Stéphane Bancel expressed confidence in Moderna’s first quarter, touting the revenue numbers as a sign of the company’s return to prosperity.
May 1, 2026
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3 min read
·
Annalee Armstrong
Cancer
AACR 2026: Combo therapies by Moderna, Marengo show promise in skin, breast cancer
Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response.
April 28, 2026
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5 min read
·
Andrea Park
Cancer
AACR 2026: Moderna, Revolution, Zymeworks and BeOne showcase new data
Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer.
April 21, 2026
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4 min read
·
Tristan Manalac
Vaccines
Flu Vaccine Rejection Imperils Moderna’s Breakeven Plans
Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.
February 12, 2026
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4 min read
·
Dan Samorodnitsky
Vaccines
Moderna’s mRNA Tech Could Boost Flu Shot Efficacy. Americans Will Have To Wait
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
February 16, 2026
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3 min read
·
Annalee Armstrong
FDA
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.
February 18, 2026
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3 min read
·
Heather McKenzie
FDA
Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
February 13, 2026
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6 min read
·
Heather McKenzie
Regulatory
Amid US ordeal, Moderna wins EU approval for flu/COVID-19 combo shot
In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
April 22, 2026
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2 min read
·
Tristan Manalac
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