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Jul 31, 2026
FDA's advisory committee voted 9-0 that Moderna's mRNA flu vaccine mFlusiva benefits outweigh risks for adults 50-64 and 65+, clearing a key hurdle before an Aug. 5, 2026 decision. The FDA initially declined to review the BLA before reversing course.
Jul 25, 2026
The FDA has refused to file Moderna's flu vaccine candidate mRNA-1010. The company will push forward outside the U.S. and pause its combination flu vaccine, while expressing disappointment over the decision's regulatory implications.
Jul 22, 2026
The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.
Jul 16, 2026
Moderna awaits an August 2026 FDA decision on its mRNA flu vaccine while expanding into oncology, autoimmune disease, and monkeypox. Its COVID-19 vaccine Spikevax remains central amid financial losses and cautious analyst sentiment.
Jun 20, 2026
The FDA reversed its initial rejection of Moderna's mRNA flu vaccine, agreeing to a normal review after public backlash, while a federal judge invalidated the ACIP advisory committee, leaving the US without functioning vaccine oversight. Moderna's vaccine showed 26.6% greater efficacy than standard flu shots in clinical trials.
Jun 19, 2026
An FDA advisory panel unanimously recommended approval of Moderna's mRNA flu vaccine mFlusiva for adults 50 and older. The vaccine showed a 27% reduction in flu cases versus a standard shot. A final FDA decision is expected by early August.
Jun 12, 2026
Personalized mRNA vaccines showed promise in pancreatic cancer trials with 7 of 16 patients in remission after five years. Stage 2 melanoma patients saw a 50% decreased death risk with personalized mRNA vaccines. U.S. funding cuts and policy shifts have stalled domestic mRNA cancer research while companies move trials abroad.
Jun 11, 2026
Long-term data from ASCO 2026 shows the personalized cancer vaccine Intismeran Autogene, combined with Keytruda, reduces recurrence or death risk by 49% in high-risk melanoma patients. Developed by MSD and Moderna, the vaccine uses AI to select neoantigens from a patient's tumor and mRNA technology to create a personalized treatment. The results signal a major advance for a field that had struggled for decades, spurring similar development efforts by other companies.
May 13, 2026
The FDA reversed its refusal to review Moderna’s mRNA flu vaccine application and accepted a revised filing with split age cohorts and a post-market study for adults over 65. The reversal came amid broader vaccine regulatory uncertainty and industry concern about unpredictable review timelines.
May 11, 2026
The S&P 500 has swung to a loss for the year as volatility, geopolitical strains and profit-taking weigh on large-cap stocks. SanDisk, Venture Global and Moderna were among the top gainers.
May 02, 2026
Vanguard increased its Moderna stake by 1.0% in the fourth quarter to 41.6 million shares worth $1.23 billion. Other institutional investors also adjusted positions, while 75.33% of the stock is held by institutions and hedge funds.
Apr 29, 2026
A phase 3 trial of an mRNA H5N1 bird flu vaccine is recruiting 4,000 volunteers in the UK and US. The Moderna-sponsored study aims to assess immune responses against emerging strains as the virus continues to evolve in mammals.
Apr 25, 2026
Moderna shares rose after the company reported quarterly results that beat earnings and revenue estimates. The stock move came as investors also weighed an FDA refusal-to-file for its mRNA flu vaccine and ongoing funding concerns.
Apr 24, 2026
Moderna reported Q4 2025 revenue of $678 million, down 30%, and a net loss of $826 million, improved from a $1.1 billion loss a year earlier. The company also issued 2026 revenue and expense targets.
Apr 22, 2026
mRNA cancer vaccines showed promising pancreatic cancer trial results and boosted tumor-fighting drugs in other research. U.S. officials canceled $500 million in vaccine funding, while the NCI is backing a $200 million cancer vaccine partnership.
Apr 22, 2026
The UK has begun a 4,000-volunteer H5N1 bird flu vaccine trial using mRNA technology. The study will assess safety and immune response, with CEPI providing £40m in funding.
Apr 18, 2026
The FDA plans to make one study the default for some new drug approvals instead of two robust clinical trials. The shift could have its biggest effect on drugs for common ailments.
Apr 13, 2026
NVIDIA and Eli Lilly announced a $1 billion AI co-innovation lab as AI drug discovery expands across research, trials and manufacturing. Companies including Recursion and Tempus are using large biological and clinical datasets to speed development and support precision medicine.
Apr 06, 2026
Blackstone closed its sixth dedicated life sciences fund at a $6.3 billion hard cap, the largest private fund raised for the sector. The vehicle is nearly 40% larger than its 2020 predecessor and targets late-stage drug assets.
Apr 02, 2026
Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.
