The FDA approved GSK's bepirovirsen for adults with chronic hepatitis B on nucleoside therapy, based on phase 3 trials showing 19% functional cure. The FDA has approved Hibsago (bepirovirsen), GSK’s antisense oligonucleotide, for adults with chronic hepatitis B who are already taking…
NASHVILLE — In this Healio video, Arun B. Jesudian, MD, discusses hepatitis B developments including new therapies for highly selective patients, updated treatment guidelines and different vaccination recommendations from the ACG Annual Meeting.“The hepatitis B space is changing and, particularly,…
Dec 20, 2024, 19:27 ET Alhemo® is designed to block a protein called TFPI in the body that stops blood from clotting. By blocking TFPI, Alhemo® improves the production of thrombin, a protein that helps to clot the blood and prevent bleeding, when…
Edwards Lifesciences reported past FDA approvals for its PASCAL Precision system for tricuspid valve repair and PASCAL Ace with Capture Clarity for degenerative mitral TEER, giving the business a broader U.S. transcatheter repair toolkit for patients who are not good candidates…
The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic device to aid in the selection of patients with chronic HBV infection for treatment with antiviral... FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment…
GSK’s bepirovirsen (Hibsago) has secured FDA approval for the treatment of chronic hepatitis B virus (HBV), when used with existing antiviral therapy in adults without cirrhosis. “This is the start of... Thank you for visiting nature.com. You are using…
Full results from the pivotal B-Well 1 and B-Well 2 phase 3 trials confirm that bepirovirsen delivers statistically significant functional cure rates in chronic hepatitis B. Bepirovirsen (GSK/Ionis...
FRIDAY, Oct. 23, 2026 (HealthDay News) — Some adults with chronic hepatitis B may now have a path to something today’s treatments rarely deliver — stopping all medication while the virus stays in check. The U.S. Food and Drug Administration on Tuesday approved…
Jordan Feld, MD, MPH, discusses bepirovirsen's approval and how capsid assembly modulators and gene editing could lead to a true hepatitis B cure. The FDA recently approved bepirovirsen (Hibsago; GSK), the first antisense oligonucleotide to treat chronic hepatitis B.1 “This is…
The FDA has drafted new recommendations on the development of drugs to treat pediatric patients with HIV meant to be applied on a global scale. The FDA has drafted new recommendations for the development of drugs to treat pediatric patients…
Regulators' decisions on new medicines: FDA, EMA, MHRA and other approvals, accelerated approvals, review dates and new uses for existing drugs.
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