The U.S. Food and Drug Administration (FDA) has given approval to TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in children. This groundbreaking approval makes TREMFYA® the first and only IL-23 inhibitor available for pediatric patients, offering a new ray of hope for thousands of children affected by these chronic conditions.
The U.S. Food and Drug Administration (FDA) has officially approved Eli Lilly and Company’s Inluriyo (imlunestrant), a new oral therapy for adult patients with advanced or metastatic estrogen receptor-positive (ER+), HER2-negative breast cancer that has an ESR1 mutation. The approval is based on the pivotal Phase 3 EMBER-3 trial, which demonstrated that Inluriyo significantly reduced the risk of disease progression or death by 38% in this patient population, offering a new and convenient treatment option for a challenging form of breast cancer.
U.S. Food and Drug Administration (FDA) has officially approved INLEXZO™ (gemcitabine intravesical system), a novel drug-delivery system from Johnson & Johnson set to revolutionize care for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This first-of-its-kind therapy offers a significant bladder-sparing alternative for a high-risk patient group often facing complete bladder removal. Clinical trials showed an 82% complete response rate, marking a major advancement in bladder cancer treatment.
The U.S. Food and Drug Administration (FDA) has broadened the approved use of Amgen’s Repatha (evolocumab) for adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C).
The U.S. Food and Drug Administration (FDA) has given the green light to a new, prefilled syringe presentation of GSK’s highly effective shingles vaccine, Shingrix.
The U.S. Food and Drug Administration (FDA) has officially approved an updated label for Eli Lilly’s groundbreaking Alzheimer’s drug, Kisunla (donanemab-azbt). This significant update introduces a new, more gradual dosing schedule specifically designed to enhance patient safety by reducing the risk of amyloid-related imaging abnormalities (ARIA), a critical side effect.
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
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 [Read More…]
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.
EMRELIS™ (telisotuzumab vedotin-tllv) used for previously treated adult patients with advanced non-small cell lung cancer (NSCLC) exhibiting high c-Met protein overexpression.
