FDA Approves New FcRN Blocker to Treat Generalized Myasthenia Gravis
Johnson & Johnson has received U.S. Food and Drug Administration (FDA) approval for IMAAVY (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis
FDA Accelerates Approval for Rare Kidney Disease
The U.S. Food and Drug Administration has granted accelerated approval for Novartis’ Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
Triglyceride Drug Approved to Treat Adults with FCS
Tryngolza (olezarsen) has been approved by the U.S. Food and Drug Administration to be used with diet to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome.
Myths & Facts: GLP-1 Drugs for Weight Loss
Misconceptions about GLP-1 drugs could interfere with patients’ efforts to achieve their weight-loss goals.
Diagnosing and Treating Infant Botulism
Since the approval of BabyBIG, the only treatment for this rare but life-threatening disease affecting infants mostly under 6 months, the mortality rate is now less than 15 percent.
FDA Approves New Medication for Acute Pain
The U.S. Food and Drug Administration has approved Vertex Pharmaceutical’s Journavx (suzetrigine), a new type of prescription pain medication for adults to treat moderate to severe acute pain.
New Biosimilar Autoimmune Disease Treatment Approved by FDA
Celltrion’s Avtozma (tocilizumabanoh), a biosimilar to Actemra (tocilizumab), in both intravenous (IV)and subcutaneous (SC) formulations, has been approved by the U.S. Food and Drug Administration.
FDA Approves New Drug to Treat UTIs
The U.S. Food and Drug Administration (FDA) has approved a new type of antibiotic to treat urinary tract infections (UTIs).
CSL Begins Enrollment for Hizentra Study for POTS
CSL Ltd. has begun enrolling U.S. patients in a Phase III late-stage randomized control trial to assess whether Hizentra subcutaneous immune globulin (SCIG) can alleviate symptoms of postural orthostatic tachycardia syndrome (POTS) — a blood circulation disorder that is one of the most common and disabling symptoms of long COVID with no approved therapies. The […]
FDA Approves Celltrion’s Steqeyma to Treat Autoimmune Diseases
Celltrion has received U.S. Food and Drug Administration approval for its autoimmune disease treatment drug Steqeyma, a biosimilar of Johnson & Johnson’s Stelara (ustekinumab).
