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Aug 21, 2026
Moderna and Merck's personalized mRNA cancer vaccine, intismeran autogene, showed promising Phase 3 results in preventing melanoma recurrence. Combined with Keytruda, it cut recurrence risk by half and reduced spread by 59% in earlier data. The treatment could reach patients within two years pending regulatory approval.
Aug 20, 2026
Merck and Moderna's personalized mRNA cancer vaccine combined with Keytruda significantly reduced melanoma recurrence risk in a Phase 3 trial. The FDA has not yet approved the vaccine, with potential availability expected by early 2027.
Aug 19, 2026
Merck and Moderna announced that their personalized mRNA cancer vaccine intismeran, combined with Keytruda, slowed melanoma recurrence in a late-stage trial. It is the first randomized Phase 3 trial to prove the benefit of neoantigen vaccines.
Jul 19, 2026
Arbutus and Genevant filed three new lawsuits against Pfizer and BioNTech over mRNA vaccine lipid nanoparticle patents, shortly after receiving a $178 million payment from Moderna. Sanofi also launched two separate patent suits against Pfizer and Moderna. A Delaware court previously narrowed Moderna's defenses in a related case.
Aug 02, 2026
Recent studies show microbiome modulation boosts chemotherapy accumulation, peptide-based mRNA vaccines shrink neuroblastoma tumors by 70%, and engineered LNPs enhance lymph node delivery while cutting side effects.
Aug 02, 2026
Moderna posted Q2 2026 revenue of $145 million and a GAAP net loss of $0.8 billion, while improving its 2026 spending outlook. Its norovirus candidate missed Phase 3 interim criteria, and mFLUSIVA faces an August 5 PDUFA decision.
Aug 08, 2026
FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine for adults 50+. It was 27% more effective than standard flu shots in a large trial. The approval came after earlier FDA pushback.
Jun 19, 2026
FDA's vaccine advisory committee unanimously recommended Moderna's mRNA flu vaccine mFlusiva for adults 50 and over, the committee's first new vaccine review since 2023. The FDA expects an approval decision by Aug 5, 2026.
May 27, 2026
The FDA replaced the two-trial approval requirement with a single pivotal trial standard, launched an AI pilot with AstraZeneca and Amgen, and extended the camizestrant review. A key FDA official is departing. AstraZeneca posted $58.74 billion in revenue.
Aug 05, 2026
Oncotelic granted Lunai Bioworks worldwide rights to its nose-to-brain delivery system for biodefense and Alzheimer's. Nearly 98% of small-molecule drugs fail to cross the blood-brain barrier.
Aug 09, 2026
The FDA approved Moderna's mFlusiva, the first mRNA-based flu vaccine, for adults 50 and older. Full approval covers ages 50-64; accelerated approval covers 65+. Moderna expects availability later this year, pending CDC recommendation.
Aug 08, 2026
A WashU Medicine study found Moderna's investigational mRNA flu vaccine could reduce hospitalizations and deaths, offering longer protection than current shots. If FDA-approved, it would be the first mRNA flu vaccine, with a decision possible by early August.
Jul 12, 2026
WHO has launched the PARTNERS clinical trial testing MBP134 and remdesivir for Bundibugyo virus disease in the DRC. Advisers recommend limiting all candidate Ebola drugs to clinical trials. The outbreak has caused 1,792 confirmed cases and 625 deaths as of July 9.
Jul 25, 2026
Moderna shares fell 11% on Friday, eyeing their worst week since August 2025 after a June surge. An FDA panel voted 9-0 for its mRNA-1010 flu vaccine, with a decision due by August 5.
Jul 21, 2026
Crispr Therapeutics AG trades at $47.78 with a $4.78B market cap, while Moderna trades at $61.82 with a $25.06B market cap, about 5.2 times larger. Both face losses, but CRISPR's Casgevy approval and Moderna's pipeline advances shape divergent analyst outlooks.
Jul 23, 2026
AI-driven drug discovery attracts major investment and partnerships: Galux closes $29M Series B, LG Chem partners with LabGenius on cancer antibodies, Cheiron raises $8M seed, and Peptris secures $7.7M. Galux also teams with AimedBio on BBB-crossing proteins.
Aug 07, 2026
Moderna posted a narrower-than-expected Q2 loss, with mFLUSIVA awaiting an FDA decision and a Phase 3 norovirus trial missing early success criteria. It reaffirmed 2026 revenue growth and cash guidance.
Jul 27, 2026
KEYNOTE-942 five-year data: intismeran autogene plus Keytruda reduced melanoma recurrence risk by 49% and kept 68.8% of patients cancer-free versus 49.1% with Keytruda alone. Distant metastasis or death risk fell 59%.
Apr 05, 2026
Biotech investors are closely watching cystic fibrosis drug trials, rare-disease therapies and regulatory catalysts. Sionna Therapeutics is advancing a new CF drug class, while Praxis Precision Medicines targets essential tremor. FDA staffing challenges add uncertainty to approval timelines.
Aug 02, 2026
Moderna reported a second-quarter loss of $782 million and a first-quarter loss of $1.34 billion, both beating expectations. The company appointed a new Chief Commercial Officer ahead of vaccine launches and disclosed CFO restricted stock unit transactions.
