Selarsdi Approved as Biosimilar to Stelara to Treat Plaque Psoriasis and Psoriatic Arthritis
The U.S. Food and Drug Admini-stration has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.
FDA Grants wilate Orphan Drug Exclusivity
The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for Octapharma’s wilate, von Willebrand factor/coagulation factor VIII complex (human) lyophilized powder for solution for intravenous injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease (VWD).
Cryoprecipitate, Fibrinogen Concentrates and New Pathogen Reduced Cryo Product Vie for Use in Massive Hemorrhage
Does the shorter preparation time for fibrinogen concentrates make them a reasonable option in lieu of IFC in defined patient populations experiencing massive hemorrhage?
Albumin Administration Superior to Ringer’s Lactate for Maintaining Normovolemia During Major Surgical Hemorrhage
Investigators at the Bern University Hospital conducted a single-center randomized clinical trial to quantify and compare the PVE properties of iso-oncotic 5% albumin, hyper-oncotic 20% albumin and Ringer’s lactate (RL) in patients undergoing radical cystectomy.
Emicizumab Prophylaxis Efficacious and Well-Tolerated in Infants with Severe Hemophilia A Without Inhibitors
The Phase IIIb study of emicizumab shows promise for reducing risk of spontaneous and traumatic bleeds in infants with hemophilia A.
FDA Approves New Safety Labeling for Opioid Medications
FDA approved and implemented updated warning labels for all opioid prescriptions.
FDA Approves First Cell Therapy to Treat Melanoma
FDA approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with unresectable melanoma or metastatic melanoma that previously has been treated with other therapies.
Third Humira Biosimilar Is Approved by FDA
FDA has approved Alvotech’s Simlandi (adalimumab-ryvk) as the third interchangeable Humira biosimilar.
New Guidance Recommends All Federal Facilities Have Access to Naloxone
The U.S. Department of Health and Human Services and the General Services Administration have announced new guidance recommending that all federal facilities across the nation include overdose reversal medications in their safety stations on site.
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.
