News & Updates

Treatment with high-dose VE303, a defined bacterial consortium composed of eight strains of commensal Clostridia, was associated with a significant reduction in antibiotic resistance genes (ARGs) among individuals with Clostridioides difficile infection (CDI), according to the phase II CONSORTIUM* study presented at IDWeek 2024.

Transplantation of maternal faecal microbiota may safely correct gut microbiota imbalance in infants born via caesarean section (C-section), according to the results of the SECFLOR* trial.

Pooled saliva tests for congenital cytomegalovirus (cCMV) infection are both accurate and cost-efficient, potentially transforming the implementation of universal cCMV screening, suggests a study presented at IDWeek 2024.

A single injection of mRNA-1403, a multivalent norovirus mRNA vaccine, induces a robust serum histo-blood group antigen (HBGA)-blocking antibody response across all dose levels in adults, as shown by interim results of an ongoing phase I/II trial presented at IDWeek 2024. Comparable findings have been observed with serum virus-like particle (VLP)-binding antibody responses.

Interim data from a phase II trial demonstrate the safety and tolerability of the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in adolescents. MVA-BN is a live attenuated, non-replicating orthopoxvirus vaccine licensed in the US for smallpox and mpox prevention.

Once-weekly treatment with islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor, led to sustained high rates of viral suppression at week 48 among people with HIV, according to the secondary endpoint results of a phase II study presented at IDWeek 2024.

New drug applications approved by US FDA as of 1-15 November 2024 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

The Visby Medical Women’s Sexual Health Test – a single-use PCR platform that combines sample preparation, nucleic acid amplification, and detection into an integrated device – offers an over-the-counter solution for the detection of DNA from pathogens such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV).