The U.S. Food and Drug Administration (FDA) has recently approved expanded use of Amgen’s innovative product, marketed as Uplizna. This groundbreaking decision marks a significant milestone in the treatment of rare immune disorders. Also known as inebilizumab, Uplizna is the first FDA-approved therapy specifically targeting conditions associated with immunoglobulin G4 (IgG4-RD). This rare disorder, characterized by an overactive immune system that causes persistent inflammation and tissue scarring in vital organs such as the pancreas, liver, and kidneys, affects approximately 20,000 people across the United States.
On Tuesday, shares of Supernus Pharmaceuticals $SUPN saw an impressive 5.5% increase following the approval from the U.S. Food and Drug Administration (FDA) of their new device, ONAPGO. This innovative treatment for motor complications in adults with advancing Parkinson's disease is set to hit the U.S. market by the second quarter of 2025. As the first FDA-approved wearable subcutaneous infusion device of its kind, ONAPGO is pioneering new possibilities in the treatment of neurodegenerative diseases.
EssilorLuxottica $EL.PA, a leading company in the optics and eyewear industry, has announced a significant milestone in the advancement of its technologies. On Monday, the company confirmed receiving clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking over-the-counter Nuance $NUAN audio glasses.