On September 19, 2025, the U.S. Food and Drug Administration (FDA) approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph, Merck) for subcutaneous injection. It is the first approval of Keytruda in a non-intravenous formulation, providing therapy to adult and pediatric patients (12 years and older) for all approved solid tumor indications of IV Keytruda. Clinical Evidence […]
The FDA just recently approved first time treatment for patients struggling from Barth Syndrome, a rare life-threatening disease which affects the mitochondria, powerhouse of the cell. Barth Syndrome mainly affects males and often begins in infancy with severe heart failure, leading to high chances of early death. Those who make it to adolescence & adulthood, […]
A new treatment path for patients with rare active immunoglobulin G4-related disease after the European Medicine’s Agency decided on extending the therapeutic indication of Uplizna (inebilizumab) to include patients with Ig4 related autoimmune disease. IgG4-RD is a rare, chronic autoimmune disease in which the body’s immune system attacks healthy tissues, leading to inflammation and scarring in one […]
The Medicines & Healthcare Regulatory Agency (MHRA) has approved vorasidenib (Voranigo) for the treatment of adults and children aged 12 and older with specific types of brain tumors, explicitly grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 mutation. This new selection is intended for patients who do not require immediate chemotherapy or radiotherapy […]
Patients with von Willebrand disease (VWD) now have expanded treatment options, following the FDA’s approval of Vonvendi for prophylactic use in adults aged 18 and older, as well as for managing bleeding episodes and perioperative care in pediatric patients. Vonvendi was previously authorized solely for on-demand treatment of bleeding episodes & perioperative use in adults […]
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