Eli Lilly announced its novel cancer drug, olomorasib, has been granted Breakthrough Therapy designation by the U.S. FDA. This significant milestone aims to expedite the development of the treatment for patients with advanced KRAS G12C-mutated non-small cell lung cancer, a historically difficult-to-treat condition.
Pfizer and BioNTech’s updated COMIRNATY vaccine, targeting the LP.8.1 COVID-19 sublineage, gained FDA approval for use in seniors and high-risk individuals aged 5 to 64. The vaccine promises enhanced immune defense against current variants and is set for immediate distribution across the U.S.
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).
Novo Nordisk’s Wegovy has received FDA approval to treat MASH, a serious liver disease linked to obesity and diabetes. This new indication highlights Wegovy’s role in improving liver fibrosis and reversing liver damage alongside lifestyle changes.
The European Commission (EC) has granted a landmark approval for Johnson & Johnson’s DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma (SMM). This decision marks a significant shift in the treatment paradigm for this precursor to active multiple myeloma, moving away from the traditional “watch and wait” approach to proactive, early therapeutic intervention.
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.
The European Commission has approved AstraZeneca’s Imfinzi, establishing a new standard of care for muscle-invasive bladder cancer. This landmark decision makes Imfinzi the first perioperative immunotherapy available to patients in the EU, following a pivotal Phase III trial where the regimen significantly reduced the risk of cancer recurrence and death. This approval marks a transformative moment for patients with this high-risk disease.
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.
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.
