RxNews®

March 25, 2026 - Denali Therapeutics announced the FDA approval of Avlayah (tividenofusp alfa-eknm), for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.

March 26, 2026 - Novo Nordisk announced the FDA approval of Awiqli (insulin icodec-abae), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

March 26, 2026 - The FDA announced the approval of Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel), for the treatment of pediatric patients with severe leukocyte adhesion deficiency- I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant (HSCT).

March 25, 2026 - The FDA announced the approval of Corcept Therapeutics’ Lifyorli (relacorilant), in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

March 30, 2026 - Teva announced the FDA approval of Ponlimsi (denosumab-adet), biosimilar to Amgen’s Prolia® (denosumab).

March 30, 2026 - Biogen announced the FDA approval of a high dose regimen of Spinraza (nusinersen), for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

March 31, 2026 - The FDA alerted patients and health care professionals about serious postmarketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with Tavneos (avacopan).