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FDA approves empagliflozin to reduce CV death, HF hospitalization in HFpEF

The FDA approved an expanded indication for the SGLT2 inhibitor empagliflozin to reduce the risk for CV death and HF hospitalization in adults with HF with reduced or preserved ejection fraction, according to an agency press release.Empagliflozin (Jardiance, Boehringer Ingelheim) was originally approved 2014 to improve glucose response for adults with type 2 diabetes. In August, the FDA approved
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Preserflo microshunt shows good outcomes out to 2 years in primary open-angle glaucoma

Two-year results of a multicenter European study showed that the Preserflo microshunt, an ab externo filtration surgery device, safely reduced IOP in eyes with primary open-angle glaucoma.In 81 patients aged between 18 and 85 years who were not adequately controlled on maximal tolerated medical therapy, mean IOP decreased from 21.7 mm Hg at baseline to 14.5 mm Hg at 1 year and was stable at 2
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Interval between COVID-19 vaccine doses can be up to 8 weeks, CDC says

The interval between the first and second doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines can be up to 8 weeks for certain people, the CDC said in updated interim guidance. Previous guidance stated that first and second doses should be separated by 3 weeks for the Pfizer-BioNTech vaccine and 4 weeks for the Moderna vaccine.
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Agomelatine safe, effective to treat adolescent MDD

Agomelatine proved safe and effective in treating adolescents with major depressive disorder who received psychosocial counseling, according to a double-blind randomized controlled phase 3 trial published in Lancet Psychiatry.“Established recommendations and guidelines for treatment of moderate to severe depression in children and adolescents recommend initial treatment with
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AI-based image analysis tool for intravascular OCT cleared by FDA

Dyad Medical announced its automated image analysis tool to view and quantify intravascular OCT images has been granted clearance by the FDA.Intravascular OCT is used to conduct preclinical and clinical evaluations to optimize stent design, but manual interpretation and analysis of the images is time-consuming, so an automated solution (Libby IAAA) using artificial intelligence was developed, the
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How might clinicians find optimal candidates for novel type 1 diabetes therapies?

Endocrine Today | Guidance on staging pre-symptomatic type 1 diabetes was published in 2015; however, the guidance is not always top of mind in primary care or even in specialty care. Yet, we know as many as 90% of people who go on to develop type 1 diabetes have no family history of type 1 diabetes.There are research pathways right now in the United States and internationally to find candidates for therapy
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Nonviral CAR-T is 'remarkably safe' and clinically active in B-cell ALL

More than 60% of patients with relapsed or refractory B-cell acute lymphoblastic leukemia achieved initial complete remission after receiving an investigational chimeric antigen receptor T-cell therapy, phase 1/phase 2 study results showed.By their initial 1-month evaluation, 73% of patients who received the highest dose levels had a complete response to therapy, according to findings presented
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Rhinovirus, RSV, varicella infections precede Kawasaki disease outbreaks by 1 to 3 months

Infections caused by rhinovirus, respiratory syncytial virus and varicella, precede Kawasaki disease outbreaks by 1 to 3 months in children and young adults in South Korea, according to data published in JAMA Network Open. “The etiological characteristics of [Kawasaki disease (KD)] remain unknown; however, a potential association between KD and infectious diseases has been previously
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Addition of darolutamide to ADT, docetaxel prolongs OS in metastatic prostate cancer

SAN FRANCISCO — The addition of darolutamide to androgen deprivation therapy and docetaxel prolonged OS among men with metastatic hormone-sensitive prostate cancer, according to study results presented at ASCO Genitourinary Cancers Symposium. The regimen reduced risk for death by 32.5%.
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Mental disorders generally lower in immigrant/refugee vs. nonimmigrant youths

Prevalence of mental disorders among first- and second-generation immigrant and refugee children and youth was generally lower relative to similar populations of nonimmigrants, per a Canadian cohort study published in JAMA Network Open.“For at least half of all mental health problems across the life course, onset is in childhood or adolescence. Understanding mental disorder prevalence prior
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