The FDA has proposed new draft guidance to improve the accuracy of pulse oximeters across all skin tones, addressing long-standing concerns about potential disparities in performance.
The FDA is seeking a cap on nicotine levels in cigarettes and certain tobacco products at minimally or nonaddictive levels. This initiative, if finalized, would be what the FDA calls a “significant step”...
Acoramidis, an oral therapy, is now approved to reduce cardiovascular-related deaths and hospitalizations in adults with hereditary or wild-type ATTR-CM.
Plozasiran, a first-in-class RNA interference therapeutic, reduced triglycerides by 80% and lowered the risk of acute pancreatitis by 83% in patients with familial chylomicronemia syndrome (FCS), earning...
The FDA has approved concizumab-mtci, a daily subcutaneous treatment to reduce bleeding for patients with hemophilia who have clotting factor inhibitors.
Crinecerfont, a first-in-class therapy, improved androgen control and reduced reliance on high-dose glucocorticoids for patients with congenital adrenal hyperplasia.
The FDA has approved a novel therapy for patients with hemophilia A or B without inhibitors. Clinical trials showed it significantly reduces bleeding episodes by targeting a new protein in the blood...
Two randomized, double-blind studies demonstrated that a new antipsychotic treatment for adult patients with schizophrenia may lead to a meaningful reduction in symptoms.
