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739,928 Results for "moderna therapeutics inc".
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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
·
4 min read
·
Dan Samorodnitsky
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
·
3 min read
·
Heather McKenzie
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
·
3 min read
·
Annalee Armstrong
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
·
6 min read
·
Heather McKenzie
FDA
Moderna’s mRNA Vaccine Refusal Comes Amid Global Advanced Therapies Push
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
February 17, 2026
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5 min read
·
Heather McKenzie
Earnings
Moderna’s FDA Challenges Stymie Breakeven Goal in ‘Fresh and Fluid’ Situation
Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
February 13, 2026
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5 min read
·
Annalee Armstrong
Editorial
All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
February 11, 2026
·
4 min read
·
Dan Samorodnitsky
Legal
Court Rejects Two Moderna Defenses in mRNA Vaccine Patent Row With Arbutus
Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
February 18, 2026
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2 min read
·
Tristan Manalac
Vaccines
FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
February 11, 2026
·
4 min read
·
Tristan Manalac
FDA
FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
February 12, 2026
·
2 min read
·
Dan Samorodnitsky
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