To Pay or Not to Pay: Medicare’s Big Aduhelm Decision
In June, the FDA approved aducanumab (Aduhelm) to treat patients with Alzheimer’s disease using the agency’s accelerated approval pathway, despite significant concerns about the evidence regarding the drug’s safety and effectiveness. The agency’s approval decision contradicted the recommendations of its own advisory committee, which voted overwhelmingly against the evidence presented in support of the drug. […]
FDA OKs First Drug for Symptoms of Rare Liver Disease in Kids
The FDA approved odevixibat (Bylvay) for treating young children with intense itching caused by progressive familial intrahepatic cholestasis (PFIC), manufacturer Albireo Pharma announced on Tuesday. Odevixibat becomes the first therapy for the rare disease and was approved to treat pruritus in all PFIC subtypes for patients ages 3 months and older. It was described as […]
Fuzzy OS Benefits in Drug Labels; Zantac Suit Dismissed; Cancer Deaths Drop For Now
The overall survival benefits associated with use of many newly approved cancer drugs are often not clearly communicated in drug labels. (JAMA Internal Medicine) A reduced-dose CT scan of 0.3 mSv can safely be used to detect lung nodules in children with cancer without sacrificing diagnostic accuracy. (American Journal of Roentgenology) A federal judge has […]
Finerenone OK’d for Slowing Kidney Disease in T2D
The FDA approved the anti-mineralocorticoid agent finerenone (Kerendia) for slowing the progression of chronic kidney disease in type 2 diabetes patients, the agency announced on Friday. The first non-steroidal, selective mineralocorticoid receptor antagonist was approved to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, […]