Island Pharmaceuticals has secured all regulatory and ethics approvals to deploy its investigational antiviral Galidesivir under the WHO's MEURI framework during the ongoing Bundibugyo Ebola outbreak in Uganda, creating an opportunity to generate prospective human efficacy and safety data while addressing an urgent unmet medical need.
The global SNAP trial finds penicillin as effective as, and safer than cloxacillin or flucloxacillin for penicillin-susceptible Staphylococcus auerus bacteremia.
SNAP global trial finds cefazolin as effective and safer than the "antistaphlococcal" penicillins oxacillin or flucloxacillin for methicillin-sensitive S aureus bacteremia.
DOTS data on dalbavancin for complicated Staph aureus bacteremia and PeterPen interim results for ESBL bloodstream infections provide potential options to revisit first-line therapy. Megan Klatt, PharmD, BCIDP, DPLA, discusses insights around these trials and how they can affect clinical practice and stewardship.
The FDA granted Priority Review for a dolutegravir sNDA in newborns from birth, with a PDUFA action date of August 25, 2026, as the EMA simultaneously validated a parallel marketing application.
A look back at Q2 2026's most significant infectious disease developments, including landmark FDA approvals, a historic hantavirus outbreak, and an update on a mRNA influenza vaccine.
Merck has reached an agreement with the ADAP Crisis Task Force to help state AIDS Drug Assistance Programs provide doravirine/islatravir access to eligible, virologically suppressed people with HIV.
Four HIV Awareness Month conversations with Kristine Erlandson, MD; Joanne Stekler, MD, MPH; Oni Blackstock, MD, MHS; and Jason Baeten, MD, PhD, reveal what's holding back an epidemic we have the tools to end.
Investigational mRNA influenza vaccine prompts broader immune response than conventional vaccines, with activity against multiple strains.
Lao-Tzu Allan-Blitz, MD, MPH, discusses treatment strategies including resistance-guided therapy with molecular gyrA assays and the goal of potentially reintroducing ciprofloxacin as therapy for this infection.
Jared Baeten, MD, PhD, discusses what the PURPOSE 1 and 2 trial data reveal about lenacapavir adherence, long-acting PrEP candidate selection, the treatment pipeline, and access barriers for twice-yearly injectable HIV prevention.
Hackensack Meridian Health has joined Pfizer’s global phase 3 BEETHOVEN trial, aiming to enroll 1,000 participants to evaluate an investigational vaccine designed to prevent Clostridioides difficile infection in adults aged 65 years and older. Alex Lazo-Vasquez, MD, provides some insights around the trial.
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.
