Ashley Gallagher, Associate Editor

Authorized for use in professional point-of-care settings, the nucleic acid amplification diagnostic tool delivers results in 25 minutes.

Regeneron and Sanofi’s Dupilumab is the first biologic to demonstrate a clinically meaningful and statistically significant reduction in exacerbations compared with the placebo.

Increased risk for severe disease in individuals with SUD could be from co-occurring medical conditions, investigators from Boston Medical Center say.

Data indicated that waist-to-height ratio is a better indicator of outcomes in patients with HF than body mass index.

Given the promising results, the company is advancing Rinvoq to a phase 3 clinical trial for the autoimmune disorder.

Ribociclib plus endocrine therapy demonstrates a reduction in the risk of disease recurrence in patients with HR+/HER2- early breast cancer.

The results of the INSPIRE trial demonstrated that 20.3% of individuals receiving risankizumab (Skyrizi) achieved clinical remission compared to 6.2% of individuals who received the placebo.

Axicabtagene ciloleucel demonstrated a 2.5-fold increase in individuals with relapsed/refractory large B-cell lymphoma who were alive at 2 years and did not experience either cancer progression or require the need for additional cancer treatment.

Therapy from Karuna Therapeutics demonstrates an 8.4-point reduction in Positive and Negative Syndrome Scale total score compared with the placebo at week 5.

Spherix Global Insights estimates that SER-109 (Seres Therapeutics; Aimmune) will be able to challenge fecal microbiota, live-jslm in C. difficile treatment.

Phase 2B clinical trial results demonstrate that patients experienced improvement in total body and facial repigmentation.

Children in the LT-001 study treated after onset achieved or maintained additional milestones up to 7.5 years after 1-time intravenous infusion, Novartis says.

Rezafungin (Rezzayo; Cidara Therapeutics Inc, Melinta Therapeutics LLC) is the first new treatment option approved for individuals with candidemia and invasive candidiasis in more than a decade.

The test did not reach the World Health Organization’s minimum performance requirement, which is 80% sensitivity for SARS-CoV-2, in the study population.

In an additional post-hoc analysis, guselkumab demonstrated improvements at week 48, according to Janssen Pharmaceutical.

The treatment shows positive results in metastasis-free survival for men with non-metastatic hormone-sensitive prostate cancer, Pfizer and Astellas announce.

Retifanlimab-dlwr (Zynyz; Incyte) was granted FDA accelerated approval for metastatic or recurrent locally advanced Merkel cell carcinoma.

The primary outcome of the study includes an IGA score of 0 or 1, which indicated clear or almost clear skin, respectively, with a reduction, from baseline to week 16.

Blinded arms of the study will continue to evaluate the combination therapy with docetaxel vs docetaxel alone, Merck says.

Purine metabolite xanthine, found in caffeinated beverages and food, affect cell differentiation, and new study results may lead to more knowledge about why diseases such as IBD develop.

Investigators estimate that the effectiveness was higher after 1 or 2 booster doses compared with the primary series alone.

MenABCWY combination meets all 11 primary endpoints and shows that it is well tolerated, with a safety profile consistent with MenACWY (Menveo) and MenB (Bexsero).

Rivaroxaban and aspirin results in a 33% reduction in major adverse limb events both early and late following lower extremity revascularization.

Trastuzumab deruxtecan from AstraZeneca and Daiichi Sankyo meets prespecified criteria for duration of response and objective response rate.

The changes, which will be effective January 1, 2024, include pre-filled pens, vials of basal, vials of bolus, and pre-mix insulins.

Study includes healthy individuals and those who had progressive multiple sclerosis with the nasally administered treatment.

The COVID-19 pandemic was associated with an increase in rural-urban telemedicine divide across the Veteran Affairs health care system.

Eli Lilly treatment targets soluble amyloid beta and did not clear plaque or halt accumulation of amyloid in individuals treated with the drug in the A4 study.

These infections can include the central nervous system (CNS), circulation, invaded organs, lower airway, and the middle ear, with outcomes that can be permanent.

The application is based on phase 3 results from the DINAMO trial showing that Jardiance tablets significantly reduced A1C levels vs a placebo in participants aged 10 to 17 years.