Approved
Alhemo: A Breakthrough in Hemophilia Treatment – FDA Approves Novo Nordisk’s Once-Daily Prophylactic Injection for Hemophilia A and B with Inhibitors
Alhemo, Novo Nordisk, Hemophilia A and B, Inhibitors, FDA Approval, Once-Daily Prophylactic Treatment, Concizumab
Breakthrough in Familial Chylomicronemia Syndrome: FDA Approves Ionis’ Tryngolza as First Treatment
Familial Chylomicronemia Syndrome (FCS), Ionis Tryngolza, FDA Approval, Rare Genetic Hyperlipidemia, Acute Pancreatitis, Lipid-Lowering Therapy
FDA Approves Humacyte’s Symvess ATEV: A Breakthrough in Regenerative Medicine for Vascular Trauma Treatment
Humacyte, FDA approval, Symvess ATEV, regenerative medicine, vascular trauma, lab-grown blood vessels
FDA Approves Ionis’s TRYNGOLZA for Familial Chylomicronemia Syndrome, a Rare Metabolic Disorder
FDA approval, Ionis Pharmaceuticals, TRYNGOLZA, olezarsen, familial chylomicronemia syndrome (FCS), rare metabolic disorder
Rhythm Pharmaceuticals Secures Expanded FDA Approval for IMCIVREE to Treat Genetic Obesity in Children as Young as 2 Years Old
Rhythm Pharmaceuticals, IMCIVREE, setmelanotide, FDA approval, genetic obesity, Bardet-Biedl syndrome, POMC, PCSK1, LEPR deficiency, pediatric obesity treatment
Mesoblast Secures FDA Approval for Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric Steroid-Refractory Acute Graft-Versus-Host Disease
Mesoblast, Ryoncil, FDA Approval, Mesenchymal Stromal Cell Therapy, Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD), Pediatric Patients, Cell Therapy
FDA Approves Ensartinib for First-Line Treatment of ALK-Positive NSCLC
Ensartinib, ALK-positive NSCLC, FDA approval, lung cancer treatment, Xcovery Holdings
FDA Rejects Full Approval for AstraZeneca’s Andexxa Amid Safety Concerns
Andexxa, AstraZeneca, FDA, full approval, safety concerns, bleeding reversal agent, FXa inhibitors
FDA Approves Neurocrine’s Crenessity for Rare Congenital Adrenal Hyperplasia
Neurocrine Biosciences, FDA approval, Crenessity, crinecerfont, congenital adrenal hyperplasia (CAH), rare genetic disease, adrenal gland condition.
FDA Approves Expanded Use of VTAMA and Nemluvio for Atopic Dermatitis Treatment
FDA approval, atopic dermatitis, VTAMA, Nemluvio, Galderma, Organon, dermatology, skin conditions