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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07508644 |
RSV Vaccination to Reduce Recurrent AECOPD |
NOT_YET_RECRUITING | PHASE4 |
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A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus |
NOT_YET_RECRUITING | PHASE2 |
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Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine |
NOT_YET_RECRUITING | PHASE1 |
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RSV Burden in Hong Kong |
NOT_YET_RECRUITING | |
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Covid Flu A/B and RSV 4 in 1 Diagnostic Test |
COMPLETED | |
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Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings |
NOT_YET_RECRUITING | NA |
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Preparedness Through Respiratory Virus Epidemiology and Community Engagement |
RECRUITING | |
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Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy |
RECRUITING | PHASE4 |
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SURVEILLANCE, ASSESSMENT AND DETECTION OF INFLUENZA ASSOCIATED RESPIRATORY INFECTIONS IN HIV POSITIVE AND NEGATIVE INDIVIDUALS IN LUSAKA, ZAMBIA |
RECRUITING | |
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Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay |
COMPLETED |
