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

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.

Dynavax and Vaxart have entered into a license and collaboration agreement to advance Vaxart’s investigational oral COVID-19 vaccine, with phase 2b data expected in late 2026.

The federal agency gave the nod to Meitheal Pharmaceuticals for its antibiotic, Contepo, an intravenous fosfomycin offering a new mechanism of action and a new option for adults with complicated urinary tract infections, including those caused by resistant gram-negative pathogens.

The foundation has unveiled its 2025 campaign, highlighting the deadly toll and long-term consequences of these infections through nationwide events, education initiatives, and tributes throughout November.

This week review more highlights from IDWeek, and why one researcher is predicting a milder avian influenza season.

The XpertHCV test from Cepheid enables rapid, point-of-care detection of hepatitis C infection in under an hour—helping to expand access to care and reduces follow-up loss.

This week, meet SIDP's president-elect, the connection between UTIs and meat, a COVID-19 vaccine alternative, and other highlights from IDWeek.

A new genomic study reveals that up to 18% of urinary tract infections (UTIs) in Southern California may stem from E coli strains transmitted through contaminated poultry and meat, disproportionately affecting residents of low-income neighborhoods.

Moderna’s investigational cytomegalovirus (CMV) vaccine, mRNA-1647, did not meet its primary endpoint in a phase 3 trial, leading the company to discontinue its congenital CMV program while continuing studies in transplant patients.

At IDWeek, the company reported promising phase 1/2 trial results for its shingles vaccine candidate Z-1018, demonstrating strong immune responses and favorable tolerability.

A systematic review presented at IDWeek 2025 found that pneumococcal serotypes unique to Merck’s 21-valent conjugate vaccine, Capvaxive, are more prevalent among US adults and show higher rates of antibiotic resistance compared to those unique to PCV20.

Findings from the ongoing ROAR registry show that fecal microbiota, live-jslm (RBL), maintains strong efficacy and safety in preventing recurrent Clostridioides difficile infection (rCDI) in routine US clinical practice.

Combined or individual use of maternal RSVpreF and infant nirsevimab achieved high antibody levels without safety concerns, supporting current RSV prevention strategies.

A nationwide analysis found that more than 1,500 additional HIV specialists are needed—particularly in the south—to meet national HIV care targets, underscoring major geographic and socioeconomic disparities in provider access.

New 96-week results from the study show that Dovato is as effective as Biktarvy in maintaining viral suppression in adults with HIV, while leading to less weight gain and fewer drug-related adverse events.

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