New Biosimilar Autoimmune Disease Treatment Approved by FDA
Celltrion’s Avtozma (tocilizumab-anoh), a biosimilar to Actemra (tocilizumab), in both intravenous and subcutaneous formulations, has been approved by the U.S. Food and Drug Administration.
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.
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 Zepbound to Treat Obstructive Sleep Apnea
The U.S. Food and Drug Administration has authorized the use of Eli Lilly & Co.’s Zepbound for adults with obesity and moderate to severe obstructive sleep apnea, a common condition where a person struggles to breathe properly during sleep.
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.
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.
Trial Shows Experimental Cancer Drug Helped Reduce Risk of Death in Common Blood Cancer
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.
FDA Approves YESINTEK to Treat Autoimmune Diseases
Biocon Biologics has received U.S. Food and Drug Administration (FDA) approval for YESINTEK, a monoclonal antibody for the treatment of autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Y
Pfizer’s RSV Vaccine ABRYSVO Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved ABRYSVO (respiratory syncytial virus vaccine [RSV]), a bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.
