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 […]
Regulatory
AstraZeneca’s Calquence-based fixed-duration regimens gain EU approval for treating first-line CLL, offering patients a powerful, time-limited alternative to traditional continuous therapy.
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.
GSK’s Blenrep combinations have received a positive opinion from the CHMP for treating relapsed/refractory multiple myeloma, backed by strong Phase III trial results showing improved survival outcomes.
Roche’s Susvimo® has received FDA approval for diabetic retinopathy, becoming the first continuous delivery treatment offering sustained vision benefits with just one refill every nine months. Backed by strong Phase III results, the implant provides a long-term solution for millions at risk of vision loss.
Potentially Groundbreaking Treatment Could Delay or Prevent Progression to Full-Blown Myeloma.
GSK’s Blenrep combinations have been approved in Japan for treating relapsed or refractory multiple myeloma, following strong Phase III trial results demonstrating improved survival outcomes.
EMRELIS™ (telisotuzumab vedotin-tllv) used for previously treated adult patients with advanced non-small cell lung cancer (NSCLC) exhibiting high c-Met protein overexpression.
IMAAVY demonstrated a swift and significant decrease in IgG levels, a primary driver of gMG, in key adult and pediatric trials.
Adult GCA can now be treated with RINVOQ (upadacitinib), the first and only oral Janus Kinase (JAK) inhibitor authorized for this purpose.
