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).
New Drug Approved for Children with Severe Immune Disease
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.
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).
Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma
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.
UNLOXCYT Approved to Treat Metastatic cSCC
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 Observes Serious Liver Injury After Treatment with Ocaliva
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.