April 2, 2026
Drug Approvals
Avlayah™ (tividenofusp alfa-eknm) – New orphan drug approval
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.
Drug Approvals
Awiqli® (insulin icodec-abae) – New drug approval
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).
Drug Approvals
Kresladi™ (marnetegragene autotemcel) – New orphan drug approval
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).
Drug Approvals
Lifyorli™ (relacorilant) – New drug approval
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.
Drug Approvals
Ponlimsi™ (denosumab-adet) – New biosimilar approval
March 30, 2026 - Teva announced the FDA approval of Ponlimsi (denosumab-adet), biosimilar to Amgen’s Prolia® (denosumab).
Drug Approvals
Spinraza ® (nusinersen) – New formulation approval
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.
Drug Safety
Tavneos® (avacopan) – FDA alerts about serious liver injury
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).
Drug Approvals
Foundayo™ (orforglipron) – New drug approval
April 1, 2026 - The FDA announced the approval of Eli Lilly’s Foundayo (orforglipron), in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.