Revalesio, a clinical-stage biopharmaceutical company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its lead investigational therapy, RNS60, targeting acute ischemic stroke. This designation aims to expedite the development and review of RNS60, a proprietary oxygen-enriched saline designed to protect brain tissue following ischemic injury, addressing a critical gap in stroke treatment. Acute ischemic stroke, a leading cause of long-term disability and the second leading cause of death globally, often results in permanent neurological deficits despite advances in endovascular thrombectomy, which restores blood flow but does not prevent tissue damage post-reperfusion. Currently, no FDA-approved therapies exist to mitigate brain tissue loss during or after reperfusion, underscoring the urgent need for innovative treatments.
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets), expanding its indication to include treatment of people with HIV (PWH) who have an antiretroviral treatment (ART) history but are not virologically suppressed, provided they have no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine, or tenofovir.
This study investigated the association between novel triglyceride- and triglyceride-glucose-derived obesity indices and hypertension (HTN) prevalence in nonobese adults, utilizing data from 12,717 participants in the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2020, representing approximately 119 million U.S. adults. The prevalence of HTN was 49.74% overall, with 53.45% in men.
Metformin, a cornerstone therapy for type 2 diabetes mellitus, is highly effective but poses a risk of metformin-associated lactic acidosis (MALA), a rare yet potentially fatal complication, particularly in patients with impaired renal function. This case report details an 88-year-old female with type 2 diabetes and chronic kidney disease (CKD) stage III who presented with severe lactic acidosis and encephalopathy amid acute kidney injury and a recent infection.
Growth hormone deficiency (GHD) in adults, a rare disorder characterized by decreased or absent endogenous growth hormone production, leads to abnormal body composition, dyslipidemia, insulin resistance, and increased risks of metabolic syndrome, cardiovascular disease, and impaired quality of life, including cognitive and psychological issues. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have shown promise in managing related comorbidities, but adherence to the standard daily somatropin injections remains a challenge. Ascendis Pharma A/S has developed SKYTROFA® (lonapegsomatropin-tcgd), a prodrug of somatropin administered weekly, previously approved by the U.S. Food & Drug Administration (FDA) in 2021 for pediatric GHD. This study evaluates its efficacy and safety for adult GHD.
