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May 11, 2026
Tracy Beth Høeg said in her first address to staff that she will scrutinize antidepressants and RSV products used to protect babies. She said she is prioritizing the health of women and babies.
May 07, 2026
Merck's Enflonsia (clesrovimab) receives EU approval for RSV prevention in infants. Separately, researchers identify a monoclonal antibody cocktail from pediatricians' immune cells that shows potent protection against RSV and hMPV in animal studies.
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.
Mar 17, 2026
The FDA has expanded approval of GSK's Arexvy RSV vaccine to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease, based on phase 3b trial data showing noninferior immune response.
Mar 14, 2026
GSK's RSV vaccine Arexvy received expanded FDA approval to cover all high-risk adults, adding approximately 21 million Americans under 50 to the eligible population and matching competitor approvals from Pfizer and Moderna.
Mar 11, 2026
Researchers have created a nasal vaccine platform that protects mice against flu, COVID-19, SARS, and bacterial infections by activating both innate and adaptive immune systems, offering a fundamentally different approach to disease prevention.
Mar 09, 2026
New real-world effectiveness data presented at RSVVW'26 demonstrate that GSK's Arexvy RSV vaccine was associated with a 75.6% reduction in RSV-related hospitalizations among adults aged 60 and older, with exploratory findings suggesting potential benefits for cardiovascular and respiratory complications.
Feb 27, 2026
The American Medical Association and University of Minnesota's Vaccine Integrity Project are creating an independent vaccine review system after major changes at the CDC raised concerns among public health experts.
Feb 22, 2026
NanoViricides is preparing to advance NV-387 into a Phase II clinical trial for Monkeypox in the Democratic Republic of Congo, with regulatory approval received and full funding secured through recent financings totaling approximately $6.2 million.
Feb 20, 2026
Phase III SMART trial data show clesrovimab maintained consistent safety and efficacy in high-risk children across two RSV seasons, with no drug-related serious adverse events reported in either season.
Feb 15, 2026
NanoViricides has filed an orphan drug designation application with the FDA for NV-387 as a measles treatment, amid rising U.S. cases that reached 2,251 in 2025 with 3 deaths and 727 cases already reported in early 2026.
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 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
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 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 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.
