The U.S. Food and Drug Administration approved a 2 mg dose of Novo Nordisk’s Ozempic (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.
ViiV Healthcare and Janssen Pharmaceutical’s Cabenuva treatment for people living with human immunodeficiency virus (HIV-1) received a label update as adult patients now have the option to start the injectable regimen without the need for an oral lead-in period first.
AstraZeneca’s Fasenra (benralizumab) hit a roadblock in attempting to expand the medicine’s indications when the U.S. Food and Drug Administration issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
Bristol Myers Squibb’s rheumatoid arthritis drug Orencia won marketing clearance as the first medicine approved for the prevention of moderate-to-severe acute graft versus host disease (aGvHD) in patients 2 years of age and older who have received unrelated donor hematopoietic stem cell transplantation.
Pfizer’s candidate treatment for patients diagnosed with active ankylosing spondylitis (AS) was approved by the U.S. Food and Drug Administration under a supplemental New Drug Application.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older).
Janssen Pharmaceutical and Amgen received another regulatory win for Darzalex Faspro (daratumumab and hyaluronidase-fihj) as the U.S. Food and Drug Administration approved the drug in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
The U.S. Food and Drug Administration greenlit Aadi Bioscience’s Fyarro for treating a rare and aggressive form of cancer that disproportionately affects women.
The U.S. Food and Drug Administration on November 16 authorized a virtual reality system from Applied VR for reducing lower back pain after a majority of patients in a trial testing the device showed lesser discomfort.
The U.S. FDA approved Besremi (ropeginterferon alfa-2b-njft) to treat adults with polycythemia vera (PV), a blood disease caused by the overproduction of red blood cells, resulting in the thickening of blood flow and increased risks of clots.
