FDA action is no longer expected in Q3 of 2023.

Recent evidence suggests that neoadjuvant immunotherapy offers a unique opportunity to explore disease mechanisms and identify new biomarkers of immune checkpoint blockade response and resistance, according to the researchers.

The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and poly-ADP ribose polymerase, or PARP, inhibitor therapies.

A study from UCSD highlights how advances in imaging modalities and utilization could aid in the early detection of psoriatic arthritis.

The sBLA is supported by the results of the XTEND-Kids study, demonstrating a once-weekly 50 IU/kg dose of antihemophilic factor (recombinant) provides effective bleed protection in children with hemophilia A and can be used across clinical scenarios.

The cohort study focused on annual incidence, prevalence, and mortality linked to a number of cardiovascular conditions between 2015 and 2019.

Those with certain comorbidities, including peptic ulcer disease and renal failure, were at additional risk of developing Clostridioides difficile infection.

ViiV Healthcare is developing a self-injectable HIV drug similar to Cabenuva; HHS met with insurance companies to resolve COVID-19 vaccine coverage issues; the FDA has greenlit drugmaker Novo Nordisk to add reports of ileus, or intestinal blockage, to its Ozempic label.

Patients with limited English proficiency need their mobile health (mHealth) interventions tailored more closely to their needs to improve equity of access for patients with HIV.

Treatment with diazepam nasal spray resulted in a statistically significant change in time between seizure clusters, potentially reflecting a beneficial effect of intermittent rescue therapy.

Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (AMD) that could increase Medicare costs, but biosimilars could help.

Findings from the phase 2 ALYCANTE trial support axicabtagene ciloleucel as a second-line treatment for patients with relapsed/refractory (R/R) large B-cell lymphoma who are ineligible to undergo a transplant.

The researchers found that patients with cancer exposed to immune checkpoint inhibitors have a 1.3% risk of hepatitis B virus reactivation.

Researchers found that EczemaNet2 was more accurate and robust in terms of atopic dermatitis (AD) detection than its predecessor, EczemaNet1.

The dual primary end points of overall survival and progression-free survival were encouraging when patients with hormone receptor–positive (HR+), HER2-negative (HER2–) breast cancer were treated with datopotamab deruxtecan.

Patients with generalized myasthenia gravis treated with efgartigimod consistently exceeded treatment compared with placebo regardless of gender in age, disease duration, body mass index, and thymectomy.

Family history is probably the biggest risk factor that patients need to know about, said Rebecca Brooks, MD, UC Davis Health.

Guidelines aim to help the identification of ILD in patients with rheumatic disease and aid in improving the management of patients.

Exercises such as resistance training and walking were safe and effective interventions that were associated with improved frailty scores and patient-reported outcomes (PROs) in patients with multiple myeloma receiving systemic treatment.

One meta-analysis featuring 8 studies showed that more than half of patients reported a 100% reduction in their generalized tonic-clonic seizures or tonic-clonic seizures.

FAIR Health has launched a new Opioid Tracker, featuring heat maps representing opioid abuse and dependence claim lines in the United States.

Children with sickle cell disease who require hospitalization for vaso-occlusive crises can experience adverse effects for up to 12 months following hospitalization, a study found.

New data on dupilumab demonstrate the drug’s potential usefulness in treating type 2 inflammation, a role central to respiratory diseases, including chronic obstructive pulmonary disease (COPD).

The integration of novel mRNA biomarkers into the ColoAlert screening test resulted in high sensitivity and specificity for detecting colorectal cancer (CRC).

Based on findings from the phase 1/2 BCHILD trial, the FDA approved bosutinib for pediatric chronic myelogenous leukemia.