An application from GSK to increase the use of its very effective RSV vaccine, Arexvy, has been formally approved by the U.S. Food and Drug Administration (FDA). Millions of younger Americans with underlying medical issues may be protected if the vaccine is authorized for at-risk adults between the ages of […]
FDA
A significant step in Alzheimer’s care: The FDA’s updated approval for the Amyvid PET scan allows for better diagnosis and patient selection for the latest amyloid-based treatments
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as the first and only targeted biologic treatment for adults with bullous pemphigoid, a rare and debilitating autoimmune skin disease.
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of STELARA® (ustekinumab) to treat pediatric patients two years and older with moderately to severely active Crohn’s disease. This action could mark the availability of a needed new […]
In an important milestone for the treatment of hepatitis C, AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion of MAVYRET® (glecaprevir/pibrentasvir), its pangenotypic, oral, direct-acting antiviral (DAA) therapy. The new indication now covers adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. This milestone approval distinguishes […]
Abbott’s Tendyne™ device has secured FDA approval, revolutionizing mitral valve replacement. This minimally invasive system offers a crucial alternative for high-risk patients with severe mitral annular calcification, eliminating the need for open-heart surgery.
Potentially Groundbreaking Treatment Could Delay or Prevent Progression to Full-Blown Myeloma.
The Food and Drug Administration’s approval of lecanemab, a new Alzheimer’s medication shown in clinical trials to reduce the disease slowly over time.
The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
FDA stated in the letter that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes”.
