Medicines Articles
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
Amgen’s UPLIZNA has been approved by the U.S. Food and Drug Administration as the first and only treatment for adults living with Immunoglobulin G4-related disease.
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.
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.
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.
The U.S. Food and Drug Administration (FDA) has approved a new type of antibiotic to treat urinary tract infections (UTIs).
Remestemcel-L, a new treatment for children ages 2 months and older with steroid-refractory acute graft-versus-host disease, has been approved by the U.S. Food and Drug Administration.
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).
The U.S. Food and Drug Administration (FDA) has granted fast track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1-based immune checkpoint inhibitors.
Checkpoint Therapeutics’ UNLOXCYT (cosibelimab-ipdl) has been approved by the U.S. Food and Drug Administration to treat adults with metastatic cutaneous squamous cell carcinoma or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis with Ocaliva who did not have cirrhosis of the liver.
Results of a trial of GSK’s experimental cancer drug Blenrep showed that the drug used in combination with other treatments reduced the risk of death by 42 percent in multiple myeloma, at or after first relapse, compared to an existing treatment.