Island Pharmaceuticals is leveraging the WHO's MEURI framework alongside the FDA Animal Rule pathway to evaluate investigational antiviral, galidesivir, during Africa's Bundibugyo Ebola outbreak while advancing regulatory development for a potential broad-spectrum filovirus therapy.
Island Pharmaceuticals is leveraging the WHO's MEURI framework alongside the FDA Animal Rule pathway to evaluate investigational antiviral, galidesivir, during Uganda's Bundibugyo Ebola outbreak while advancing regulatory development for a potential broad-spectrum filovirus therapy.
The CDC has identified 843 domestically acquired #cyclosporiasis cases across 31 states as of Thursday, with investigators continuing to examine multiple multistate clusters and potential food sources. Separately, but related, the state of Michigan reported 1,562 confirmed cases.
This week, read about how laboratory antimicrobial susceptibility results may not predict clinical outcomes, watch a clinician discuss the DOTS and PETERPEN trials, the FDA has granted Priority Review to expand dolutegravir use to newborns with HIV, and more.
New research from Rutgers University suggests that bacterial responses to antibiotics vary significantly under nutrient-limited conditions, highlighting potential limitations of standard laboratory susceptibility testing and offering new insights into why some laboratory findings fail to predict clinical outcomes.
Accurate, rapid diagnostics capable of distinguishing Ebola from other febrile illnesses are essential to controlling the ongoing, Bundibugyo Ebola outbreak. bioMérieux is deploying its Global Fever Special Pathogens Panel to affected regions in partnership with local governments. Chuck Cooper, MD, chief medical officer at bioMérieux, offers some insights on this testing platform and the importance of coordination with African countries to secure and deliver this technology to the hot zones and beyond.
Standard susceptibility testing is performed under controlled conditions that often fail to reflect real-world infections, leading to potential misinterpretation of antibiotic activity in patients with bacteremia.
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.
Results from the global SNAP trial find penicillin as effective as, and safer than, cloxacillin or flucloxacillin for penicillin-susceptible Staphylococcus aureus bacteremia.
Results from the SNAP global trial find cefazolin as effective and safer than the antistaphylococcal penicillins cloxacillin or flucloxacillin for methicillin-sensitive S aureus bacteremia.
DOTS data on dalbavancin for complicated S aureus bacteremia and PETERPEN interim results for ESβL bloodstream infections provide potential options to revisit first-line therapy. Megan Klatt, PharmD, BCIDP, DPLA, discusses insights from 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.
