FDA News

Officials with the FDA have granted accelerated approval to encorafenib (Braftovi; Array BioPharma, a subsidiary of Pfizer) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. Read More ›

Remestemcel-L-rknd (Ryoncil; Mesoblast), the first allogeneic bone marrow–derived mesenchymal stromal cell therapy, has been FDA-approved for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients aged ≥2 months. Read More ›

Officials with Vertex Pharmaceuticals Incorporated announced that the FDA has approved suzetrigine (Journavx), a first-in-class, oral, nonopioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. Read More ›

Axsome Therapeutics, Inc., a biopharmaceutical company, has announced that the FDA has approved meloxicam and rizatriptan (Symbravo) for the acute treatment of migraine with or without aura in adults. Read More ›

Officials with Eisai Co., Ltd., and Biogen Inc. have announced the FDA nod for the supplemental biologics license application (sBLA) for once-every-4-weeks lecanemab-irmb (Leqembi) intravenous (IV) maintenance dosing. Read More ›

Vanzacaftor/tezacaftor/deutivacaftor (Alyftrek, Vertex Pharmaceuticals), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, has been approved for the treatment of cystic fibrosis (CF) in people aged ≥6 years who have at least 1 F508del mutation or another mutation in a responsive CFTR gene. Read More ›

On December 18, 2024, officials with the FDA approved remestemcel-L-rknd (Ryoncil, Mesoblast, Inc.), the first allogeneic bone marrow–derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute graft-versus-host-disease (SR-aGVHD) in pediatric patients aged ≥2 months. Read More ›

The approval makes concizumab the second anti-TFPI antibody available in the United States, following the approval of marstacimab-hncq (Hympavzi; Pfizer) in October 2024 for hemophilia A or B without inhibitors. Read More ›

The FDA has approved ustekinumab-stba (Steqeyma; Celltrion) for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis. Read More ›

Olezarsen (Tryngolza; Ionis) has been approved by the FDA for the treatment of familial chylomicronemia syndrome (FCS), a rare, inherited disorder characterized by severe hypertriglyceridemia. Read More ›