
Valneva has voluntarily withdrawn its US regulatory applications for its chikungunya vaccine, IXCHIQ, after the FDA suspended the license and placed the program on clinical hold pending investigation of a newly reported serious adverse event.

Valneva has voluntarily withdrawn its US regulatory applications for its chikungunya vaccine, IXCHIQ, after the FDA suspended the license and placed the program on clinical hold pending investigation of a newly reported serious adverse event.

The partnership is a global collaboration to develop Debio1453, a first-in-class antibiotic targeting multidrug-resistant gonorrhea, aiming to strengthen the fragile antibiotic pipeline and ensure future treatment options.

Nicholas Van Hise, PharmD, discusses a real world study, ROAR, showing that fecal microbiota, live-jslm (RBL), maintains strong efficacy and safety in preventing recurrent Clostridioides difficile infection (rCDI) in routine US clinical practice.

This week, read articles from our recent issue on topics including invasive fungal disease in transplantation, lenacapavir's role in PrEP, antimicrobial treatment around non–carbapenemase-producing carbapenem-resistant enterobacterales, and more.

We are launching our new monthly column looking at federal regulatory topics including recent decisions. In this column, we look at the FDA approvals of 2 antibiotics last month.

Here are some therapeutics and a vaccine that will be reporting data, starting a trial, or filing their data to regulatory agencies in order to seek approval this year.

This week, listen in on commentary around the changes to the childhood vaccine schedule, read SIDP's column on the next-generation antifungals as well as combination therapeutics for Candida auris, and the Clinical and Laboratory Standards Institute Subcommittee on Antimicrobial Susceptibility Testing breakpoint recommendations.

New federal guidance recommends childhood vaccines for 11 diseases, downsizing immunization protection from the previous list of 18 diseases.

This week, read about increasing influenza activity, an approach to de-escalating empiric broad spectrum antibiotics for clinically stable patients with community-onset sepsis, and more Emory Healthcare Media Day interviews around PPE and treating high-consequence infectious disease.

This week, check out our Media Day coverage from Emory, the WHO report on malaria, and more.

This week, learn more about Emory's approach around treating high-consequence infectious diseases such as Ebola, a UNC researcher's work in sequencing syphilis genomes in the search to develop a global vaccine, how the US is in danger of losing its elimination status for measles, and more.

Gilead Sciences reported positive phase 3 ARTISTRY-2 results demonstrating that a once-daily single-tablet combination of bictegravir and lenacapavir is statistically noninferior to bictegravir/emtricitabine/tenofovir alafenamide tablets in virologically suppressed adults with HIV. The company plans to file for regulatory submissions for approval.

With a novel, non–cross-resistant mechanism and phase 3 data showing noninferior efficacy to injectable standard therapy, zoliflodacin could become a novel treatment that expands clinician choice and strengthens global efforts to combat antimicrobial-resistant gonorrhea. Innoviva CMO David Altarac, MD, offers further insights about the newly-approved antibiotic and its potential place in the market.

This week, check out our coverage on 2 antibiotic FDA approvals, and clinicians weigh in on the ACIP recommendations on the hepatitis B virus (HBV) vaccine.

Reports are surfacing the federal agency is going to review products already reviewed and approved.

The federal agency approved Augmentin XR in just 2 months through the new CNPV pilot program, marking a potential step toward rebuilding domestic antibiotic manufacturing and addressing drug shortages.

This week, read our coverage on the CDC ACIP meetings on the hepatitis B virus (HBV) vaccine, modeling data on the potential consequences of HBV infections, liver cancer, and mortality when delaying the birth dose to 2 months, our latest podcast, and more.

This week, read more about the first person with a novel avian influenza strain, doxyPEP linked to increased high-level tetracycline resistance, Ethiopia investigates Marburg virus disease outbreak, and more.

The World Health Organization (WHO) is assisting Ethiopia with experts, supplies, and emergency funding as the country investigates eight suspected cases of viral hemorrhagic fever in the South Ethiopia region.

New modeling and clinical data presented by Atea Pharmaceuticals suggest that its fixed-dose combination of bemnifosbuvir and ruzasvir could offer a potent, short-duration, best-in-class treatment option for hepatitis.

This week, read about Merck's advancement of one of its HIV combination therapeutics, Pfizer's influenza vaccine data, the importance of antimicrobial resistance awareness, and more.

Merck’s investigational once-daily, 2-drug HIV regimen, doravirine/islatravir, achieved its primary efficacy and safety end points in a phase 3 trial.

AMR Action Fund CEO Henry Skinner, PhD, MBE, discusses the significance of this week, provides an update on the PASTEUR Act, and explains the differing approaches between Europe and the US with regard to push-pull incentives.

This week, learn about the first death from a meat allergy caused by ticks, Gilead reports positive top-line data showing its investigational combination therapy, bictegravir/lenacapavir was efficacious and safe, a discussion around antibiotic alternatives for MRSA, and more.

The Leapfrog Group has released its Fall 2025 Hospital Safety Grades showing states such as Utah and New Jersey remain in the top 5 of rankings. Data on health systems is also included in the report.

A healthy New Jersey man died from the allergy after eating red meat. Results from a blood sample collected post mortem found that he had been sensitized to the α-gal sugar, which is found in mammals. The blood sample results indicated the man had an extreme reaction, in line with what is seen in fatal anaphylaxis.

Gilead reports its investigational single tablet of bictegravir and lenacapavir was efficacious in people with HIV who are virologically suppressed and who switched from taking multitablet regimens. The company says its phase 3 study results will form the basis for its future regulatory submissions.

Immunocore’s first-in-human study of its bispecific, IMC-I109V, demonstrated early antiviral activity and a favorable safety profile, supporting continued development of the TCR bispecific candidate as a potential functional cure for chronic hepatitis B.

In Vir Biotechnology’s phase 2 Solstice study, 66% of participants with chronic hepatitis delta (CHD) receiving a monthly dose of combination tobevibart and elebsiran achieved undetectable hepatitis delta virus (HDV) RNA at Week 48.

This week, read about the FDA's approval of IV antibiotic, Contepo, for complicated urinary tract infections, penicillin‑binding proteins, post-exposure doxycycline for Lyme disease prevention in young children, and more.

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