gene

Revolutionary Gene Therapy Approved: Kebilidi Offers New Hope for Rare Genetic Disorder

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced a groundbreaking approval of Kebilidi (eladocagene exuparvovec-tneq), marking the first gene therapy sanctioned for the treatment of aromatic L-amino …

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Johnson & Johnson

FDA Grants Breakthrough Therapy Designation to Johnson & Johnson’s Nipocalimab for Sjögren’s Disease

SPRING HOUSE, PA — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to nipocalimab for treating adults with moderate-to-severe Sjögren’s …

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Blood

FDA Approves Hympavzi for Hemophilia Treatment, Offering Novel Approach to Bleeding Disorder Management

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis aimed at preventing or reducing bleeding episodes in patients aged 12 and older …

FDA Approves Hympavzi for Hemophilia Treatment, Offering Novel Approach to Bleeding Disorder Management Read More