
The FDA CRDAC convened on Septemeber 13 to discuss the sNDA for patisiran as a treatment for ATTR-CM, with the meeting concluding in a 9:3 vote in favor of the benefit-risk profile of patisiran.

The FDA CRDAC convened on Septemeber 13 to discuss the sNDA for patisiran as a treatment for ATTR-CM, with the meeting concluding in a 9:3 vote in favor of the benefit-risk profile of patisiran.

This new data suggests that while the Skindex-16 can help physicians to better assess severity of disease, greater levels of qualitative as well as quantitative research may be needed.

New phase 2 study findings link levosulpiride treatment for 8 weeks with improved visual and structural outcomes and no significant adverse side effects.

This research indicated that innocuous and noxious thermal as well as mechanical perception was shown to be diminished in lesions of HS patients, suggesting peripheral neuropathy.

Use of etanercept biosimilars was not associated with an increased likelihood of treatment discontinuation or disease activity among people with rheumatoid arthritis relative to continuing treatment with originator etanercept.

The analysis found any metformin use decreased the odds of developing dry AMD, particularly cumulative 2-year doses of 1 to 270 g and 271 to 600 g.

The discontinuation of LIMT-2 was announced after 4 patients experienced hepatobiliary events resulting in liver decompensation during the phase 3 study of peginterferon lambda for HDV.

The study's findings show an association between NAFLD prevalence, physical activity, and television viewing, with higher levels of physical activity paired with lower levels of television viewing leading to a statistically significantly reduced risk of NAFLD.

New data from a dose-finding trial suggests the aldosterone synthase inhibitor lorundrostat could find a role in the management of resistant or uncontrolled hypertension.

Analysis showed a higher proportion of patients with CD with NAFLD, varying across studies and regions.

A posthoc analysis of the phase 3 HAWK and HARRIER trials shows brolucizumab outperforms aflibercept at reducing SHRM thickness in eyes with nAMD.

The sNDA was announced for roflumilast cream 0.15% to the FDA, and the formulation is said to not to be disruptive to the skin barrier or contain common irritants to patients’ skin.

The advisory committee's vote may trigger an FDA decision to remove more than 250 cough medicine products from the market, or require a reformulation of such items.

In new phase 2b/3 trial data, investigational IL-17A inhibitor izokibep did not meet its primary endpoint for patients with the chronic skin disease.

Risankizumab outperformed ustekinumab in rates of clinical remission at week 24 and rates of endoscopic remission at week 48, meeting both primary endpoints of the phase 3 trial.

On September 12, 2023, the FDA announced it had issued warning letters to 8 companies, including CVS Health and Walgreens, for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.

This new research indicates that children with ARDS surviving discharge have a higher probability of readmission than was reported previously among the pediatric intensive care unit population.

An analysis of data from more than 60,000 women details associations between specific chronotypes and risk of unhealthy lifestyle behaviors as well as risk of developing type 2 diabetes.

Results from a cross-sectional analysis of NHANES data found a short sleep duration was associated with an increased risk of early AMD.

Investigators called attention to low patient-reported levels of clinician recommendation for colorectal cancer screening during wellness visits, noting the prevalence was lowest among those without insurance and without a usual source of care.

The agency anticipates the decision to update monovalent formulas of the Pfizer, Moderna, and future COVID-19 vaccines to reflect circulating variants will become an annual practice.

Crinetics announced findings from the PATHFNDR-1 trial showing the investigative oral daily drug may provide patients with the rare disease an alternative from recurring injection therapy.

New data suggest patients with nAMD on prior anti-VEGF therapy experienced improved visual acuity and macular OCT parameters after switching to faricimab.

This research shows that a basophil activation test can support decision-making by clinicians when re-introduction of baked eggs in patients with allergies is a treatment being considered.

An analysis of data from more than 20,000 women in the New York City A1c registry details the prevalence of and drivers behind racial/ethnic disparities in the incidence of type 2 diabetes following gestational diabetes mellitus.

Findings from two recent studies provide insight into the association between anti-VEGF treatment for retinal diseases and the risk of kidney injury.

At ERS International Congress 2023, new data related to use of sotatercept offered providers additional insight into the effects of the agent in people with PAH.

Results from the study found independent associations between handgrip strength, abPG-SGA, and SaskIBD-NRT with risk of IBD-related hospitalization, further noting clinical frailty scale and subjective global assessment were not associated with risk of hospitalization.

Investigators noted improved liver function, increased prevalence of anemia, and decreased hemoglobin concentration, hematocrit index, and estimated glomerular filtration rate among patients with HCV after 12 weeks of DAA treatment.

Stephen Ziegler, PhD, JD, discusses the challenges cannabis treatment presents as a form of complementary therapy for rheumatic disease.