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Feb 19, 2026
Moderna announced the FDA will consider approving its mRNA-based flu vaccine for older adults after resolving a dispute over clinical trial design. The vaccine showed 34.5% higher efficacy than standard flu shots in trials.
Feb 19, 2026
Moderna and Merck have begun recruiting for a Phase 2 trial testing V940, an mRNA-based personalized cancer vaccine, combined with Keytruda and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer.
Feb 13, 2026
Major pharmaceutical companies are highlighting their drug pipelines to offset upcoming patent losses, while Moderna confronts FDA rejection of its flu vaccine. The industry faces significant revenue challenges from patent cliffs in 2026.
Feb 17, 2026
Moderna posted Q4 2025 revenue of $678 million, beating analyst estimates despite a 29.8% year-over-year decline. The company reduced operating expenses by 31% while facing FDA refusal to file its flu vaccine application.
Feb 19, 2026
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-1010 seasonal influenza vaccine application, setting an August 5, 2026 review deadline after the company proposed a revised regulatory approach based on age groups.
Feb 18, 2026
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-based flu vaccine application, with a decision expected by August 5. The company modified its regulatory approach to address concerns about older adults.
Feb 18, 2026
FDA Commissioner Marty Makary outlined plans to expand over-the-counter drug access, crack down on unlawful GLP-1 compounding, and address the U.S. falling behind China in early-stage drug development.
Feb 20, 2026
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging that Moderna's next-generation COVID-19 vaccine mNEXSPIKE violates its mRNA vaccine design patent.
Feb 17, 2026
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Feb 17, 2026
A phase 1 clinical trial demonstrates that mRNA-1283, a next-generation COVID-19 vaccine encoding receptor-binding and N-terminal domains of the spike protein, induces durable T cell immunity at a 10 µg dose comparable to the standard 100 µg mRNA-1273 vaccine.
Feb 19, 2026
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
Feb 18, 2026
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
Feb 18, 2026
The FDA agreed to review Moderna's mRNA flu vaccine after initially refusing the application, while separately announcing it will drop its longtime requirement for two clinical studies to approve new drugs.
Feb 17, 2026
Two financial services firms raised their price targets for Moderna in mid-February 2026, with RBC Capital increasing its target to $30 and Evercore ISI Group raising its target to $35, both maintaining neutral ratings.
Feb 17, 2026
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
Feb 16, 2026
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
Feb 17, 2026
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially refusing, accepting a split regulatory approach with traditional approval for ages 50-64 and accelerated approval for 65 and older. Decision date set for August 5, 2026.
Feb 16, 2026
The FDA reversed its initial refusal and will now review Moderna's mRNA-based flu vaccine application, seeking full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision targeted for August 5, 2026.
Feb 15, 2026
The FDA agreed to review Moderna's mRNA flu vaccine application after initially rejecting it, reversing course within a week. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and above, with a decision expected by August 5.
Feb 14, 2026
Moderna challenges FDA's refusal to review its mRNA flu vaccine application, citing shifting regulatory expectations. The company reported Q4 revenue of $678 million as COVID vaccine uptake fell 26% in 2025.
