SPOTLIGHT -
UTI vaccine demonstrates long-term efficacy in over half of recipients
As a potential alternative to antibiotic treatments, this investigational immunization offered protection for several years.
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FDA issues Complete Response Letter for cefepime-taniborbactam NDA
The FDA has issued a Complete Response Letter for the New Drug Application of cefepime-taniborbactam, requesting additional chemistry, manufacturing, and controls data.
The clinical takeaways of the RSV immunizations
The panel discusses the importance of discussing the immunizations with patients now, as well as the value of them in future seasons.
RSV roundtable: What clinicians are witnessing in terms of RSV incidence
Last year’s historic RSV season left many wondering if this was going to become a recurring trend. Physicians weigh in on what they are seeing at their institutions in terms of infection rates.
CDC recommends nirsevimab immunization to prevent RSV in infants
The federal agency says infants of a certain age should receive this monoclonal antibody to protect against the virus.
Changing the RSV prevention landscape
From a virus that had no treatment options, to one that may be prevented in two different modalities, clinicians are hoping to see a reduction in respiratory syncytial virus (RSV) incidence rates, starting this fall.
Gepotidacin meets endpoints for uUTI studies, eyes potential FDA approval this year
With an FDA approval, it would be the first new class of oral antibiotics for uncomplicated urinary tract infections (uUTI) in over 20 years.
First mixed-race woman experiences possible HIV cure after stem cell transplant
The patient, referred to as the “New York patient,” was treated with stem cells from cord blood, and has remained HIV-free in her blood since her transplant in 2017.
CDC recommends universal screening for hepatitis B virus
The new guidance is the first update since 2008, replacing the previous risk-based recommendations.
GSK investigational hepatitis therapy will begin phase 3 trials
The therapy, bepirovirsen, is an antisense oligonucleotide that targets all Hepatitis B (HBV) messenger RNAs, and the company is hoping it will become a functional cure.
FDA accepts BLA for Pfizer maternal RSV vaccine
The federal agency set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.
No safety concerns with dapivirine ring in third trimester of pregnancy
Results reported at CROI showed that 2 cohorts of the ongoing, phase 3 DELIVER study that this form of PrEP modality posed no differences in pregnancy and infant outcomes.