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
Regulatory
AstraZeneca’s Datroway has received US FDA approval for advanced EGFR-mutated lung cancer. This first-in-class TROP2-directed therapy offers a vital new option for patients who have exhausted previous treatments.
Novo Nordisk announced that its leading diabetes medication, Ozempic® (semaglutide), has received a positive recommendation in the EU for an updated label to include peripheral arterial disease.
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 […]
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.
