The regulatory body approved AbbVie's glecaprevir/pibrentasvir (Maviret) for the treatment of acute hepatitis C virus infection in adults and children aged 3 years and older, making it the first and only therapy in the European Union approved for both acute and chronic HCV infection.
Two new complementary initiatives from CIDRAP’s Vaccine Integrity Project and The Evidence Collective aim to evaluate and improve US vaccine policymaking, governance, and public trust amid ongoing changes to the nation's immunization infrastructure.
There were a number of FDA approvals in recent weeks. Here is a listing of the approvals including the news reports and review of the phase 3 study data.
Oni Blackstock, MD, MHS, discusses why HIV prevention stalls despite breakthroughs: funding cuts, Medicaid gaps, and structural racism keep PrEP and care out of reach.
Preclinical findings demonstrate that the novel efflux pump inhibitor TXA14007 significantly enhances azithromycin activity against multidrug-resistant Gram-negative bacteria, supporting a potential new oral treatment strategy for difficult-to-treat infections. Jesus Rosado-Lugo, PhD, offers insights on the study at ASM Microbe 2026.
An FDA advisory committee voted unanimously to recommend mRNA-1010 for approval, after the Agency initially refused to review the application and HHS cancelled contracts supporting mRNA vaccine development.
An investigational dual vaccine against Lassa fever and rabies demonstrates promise against priority target plaguing West Africa.
In May 2026, the FDA approved a combination product of cefepime and zidebactam for the treatment of complicated urinary tract infections, including pyelonephritis, providing a new treatment option for multidrug-resistant gram-negative organisms. Here is a clinical overview of the newly approved antibiotic.
The FDA has approved an expanded indication for Merck's Capvaxive, allowing its use in children and adolescents aged 2 to 17 years with chronic medical conditions that increase their risk of pneumococcal disease following completion of a primary pneumococcal vaccination series.
The FDA has approved the first generic version of baloxavir marboxil (Xofluza), expanding access to a single-dose oral treatment and postexposure prophylaxis option for influenza in patients 5 years or older.
The FDA has approved tebipenem pivoxil (Utebzi), the first oral carbapenem antibiotic in the US for adults with complicated urinary tract infections, including pyelonephritis, providing an effective oral alternative to IV therapy for many patients with resistant infections.
One in five patients with chronic hepatitis B virus infection achieved functional cure in two phase 3 trials with the investigational agent.
The FDA's accelerated approval of bulvirtide for chronic hepatitis D headlined May's news. Learn more about the treatment's phase 3 clinical trial including its efficacy, safety profile, and clinician insights. May also included Viral Hepatitis Awareness Month and National Hepatitis Testing Day. Listen to a clinician talk about the significance of these awareness events.
After nearly 60 years of successful eradication in the United States, the New World screwworm (Cochliomyia hominivorax) has reemerged in North America, prompting renewed surveillance and containment efforts due to its ability to infest and destroy living tissue in animals and humans.
While Americans are being affected by Ebola and Hantavirus, the federal government has made concerted efforts to decrease biopreparedness programs, including reducing funding, and downsizing personnel who study and address high-consequence infectious diseases (HCID). Despite these efforts, the US has had protocols, infrastructure, and medical personnel in place to deal with these current situations.
Invivyd has dosed the first participants in LIBERTY, a phase 3 trial comparing VYD2311 to an mRNA COVID vaccine and coadministration, as the BLA-enabling DECLARATION trial completes enrollment.
Joanne D. Stekler, MD, MPH, discusses why many Americans still miss HIV diagnosis—and how opt-out screening, rapid tests, self-tests, and same-day treatment close the gap.
Meta-analysis finds approximately 1% of well-appearing outpatient infants aged 60 to 90 days with fever have an invasive bacterial infection.
The American Society for Microbiology (ASM) is leveraging its new phage therapy coordination efforts to connect researchers and clinicians, standardize approaches, and explore how bacteriophages could complement antibiotics in the fight against antimicrobial resistance. Colleen Kraft, MD, offers some insights on the organization's plans to help grow this medical modality.
A new multiplex blood-screening assay is streamlining transfusion safety by enabling simultaneous detection and discrimination of HIV, HBV, HCV, and hepatitis E in a single test, helping laboratories improve efficiency, reduce turnaround times, and strengthen blood supply resilience amid ongoing donation and staffing shortages. Nico Michel, PhD, of Roche Diagnostics, offers insights on this diagnostic.
A once-weekly oral HIV treatment combining islatravir and lenacapavir achieved its primary efficacy endpoint in 2 phase 3 trials, bringing the investigational regimen closer to becoming the first approved long-acting oral HIV therapy.
A novel antimicrobial susceptibility testing platform, ATB Finder, is designed to improve treatment outcomes by evaluating antibiotics under conditions that closely mirror the infection site and microbial communities found in patients. George Tetz, MD, PhD, offers insights on this platform.
The FDA's accelerated approval of this therapy provides the first approved treatment option for chronic hepatitis delta in the US. Anu Osinusi, MD, discusses how this targeted therapy is designed to slow disease progression and improve patient outcomes.
American Society for Microbiology (ASM) CEO Stefano Bertuzzi, PhD, MPH, discusses how they are reorganizing its structure to create more focused scientific divisions while maintaining collaboration across disciplines and improving member engagement.
Kelly Oakeson, PhD, explains how Utah public health officials are leveraging a statewide wastewater surveillance system to monitor measles activity, identify emerging outbreaks, and supplement traditional case reporting.
New data on flu vaccine for children counter the contention that a lack of contemporaneous randomized data justifies its removal from recommended annual immunizations.
Why people with HIV age faster: Kristine Erlandson, MD, offers expert tips on frailty, HAND screening, statins post-REPRIEVE, and avoiding ART drug interactions.
An increase in Plasmodium vivax malaria in New York City follows trends in migration from regions where it is endemic.
Effectiveness of post-exposure prophylaxis (PEP) with doxycycline for chlamydia and syphilis comes with increase in resistant gonorrhea.
PolyPid has completed its New Drug Application submission to the FDA for D-PLEX100, a novel locally administered antibiotic therapy that significantly reduced surgical site infections in a phase 3 trial and could receive a regulatory decision in early 2027.
