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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 16, 2026
Three comprehensive reports examine the monoclonal antibody landscape, covering CD47-targeted immunotherapy pipelines, competitive analysis of 180+ companies developing mAb therapeutics, and recombinant antibody market forecasts through 2033.
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
Arcturus Therapeutics will release fourth quarter and fiscal year 2025 financial results after market close on March 3, 2026, followed by a conference call at 4:30 p.m. Eastern Time.
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 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 13, 2026
A study of 434 toddlers found no association between maternal mRNA COVID-19 vaccination during or shortly before pregnancy and autism or other neurodevelopmental disorders in offspring aged 18-30 months.
Feb 12, 2026
International researchers have identified a specific antibody mutation that causes rare but serious blood clots after adenovirus-based COVID-19 vaccines or natural adenovirus infection, providing a roadmap for safer vaccine design.
Feb 13, 2026
Moderna reported Q4 revenue of $678 million, beating analyst estimates, while posting a narrower-than-expected loss of $2.11 per share. The results came as the FDA refused to review the company's mRNA flu vaccine application.
Feb 13, 2026
China now leads globally with 624 Phase 3 cancer trials, representing 48.5% of the total, while its share of global drug development has risen to 20% with investigational new drugs accounting for 30% of the world's pipeline.
Feb 12, 2026
The FDA approved pembrolizumab (Keytruda) and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian carcinoma based on Phase 3 trial data showing improved survival outcomes.
Feb 12, 2026
The European Commission has granted marketing authorization for Moderna's mNEXSPIKE (mRNA-1283) COVID-19 vaccine for individuals aged 12 years and older across all 27 EU member states plus Iceland, Liechtenstein and Norway.
Feb 10, 2026
The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.
