The U.S. Food and Drug Administration approved Oncopeptides AB’s Pepaxto (melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Novartis’ Entresto is the first therapy approved in the United States to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF).
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) for adults with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy.
Bristol Myers Squibb’s Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration for the first-line treatment of patients with advanced renal cell carcinoma.
The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva as the only complete long-acting regimen for the treatment of HIV-1 infection in adults.
The U.S. Food and Drug Administration approved Merck & Co. and Bayer AG’s heart failure drug Verquvo (vericiguat), an orally administered soluble guanylate cyclase stimulator.
Abbot received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions.
The U.S. Food and Drug Administration approved Vertex Pharmaceuticals Inc.’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for use in people with cystic fibrosis with certain rare mutations.
Sanofi and Regeneron’s Dupixent product won approval from the European Commission to treat children aged 6-11 years suffering from severe atopic dermatitis, often known as eczema.
The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.