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Feb 26, 2026
Four biotech companies went public in one week raising nearly $1 billion, signaling a potential thaw in IPO markets after years of quiet activity. Regional life sciences hubs outside Boston and San Francisco are attracting record venture funding, while regulatory uncertainty at FDA continues to concern industry leaders.
Feb 26, 2026
Moderna's seasonal influenza vaccine candidate mRNA-1010 receives FDA acceptance after initial refusal, with a PDUFA date set for August 5, 2026. The revised application proposes full approval for adults 50-64 and accelerated approval for those 65 and older.
Feb 26, 2026
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
Feb 25, 2026
Moderna partners with Recordati on propionic acidemia therapy for up to $160 million, while FDA Commissioner defends mRNA vaccine support following funding cuts and regulatory challenges.
Feb 24, 2026
Moderna and Merck are recruiting patients for a Phase 2 trial testing V940, an mRNA-based cancer vaccine, combined with Keytruda and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer.
Feb 24, 2026
The FDA reversed its decision to reject Moderna's mRNA influenza vaccine application, accepting it for review one week after an initial refusal-to-file that reportedly involved senior leaders overruling staff advice.
Feb 23, 2026
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging the company's newly approved mNEXSPIKE vaccine uses proprietary mRNA technology without authorization.
Feb 17, 2026
Moderna faces a pivotal transition from pandemic-era revenues to a diversified mRNA portfolio, with recent regulatory setbacks offset by strong RSV vaccine performance and upcoming Phase 3 oncology readouts.
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.
