May 15, 2026
Clinical Updates
Asceniv™ (immune globulin intravenous, human – slra) – Expanded indication
May 4, 2026 - ADMA Biologics announced the FDA approval of Asceniv (immune globulin intravenous, human – slra), for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).
Clinical Updates
Bizengri® (zenocutuzumab-zbco) – New indication
May 8, 2026 - The FDA announced the approval of Partner Therapeutics’ Bizengri (zenocutuzumab-zbco), for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
Clinical Updates
Ocrevus® (ocrelizumab) – Expanded indication
May 8, 2026 - The FDA approved Genentech’s Ocrevus (ocrelizumab), for the treatment of relapsing-remitting multiple sclerosis (MS), in pediatric patients 10 years of age and older who weigh 25 kg or more.
Clinical Updates
Vyvgart® (efgartigimod alfa-fcab), Vyvgart Hytrulo® (efgartigimod alfa/ hyaluronidase-qvfc) – Expanded indication
May 8, 2026 - argenx announced the FDA approval of Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc), for the treatment of adult patients with generalized myasthenia gravis (gMG).
Clinical Updates
Xpovio® (selinexor) – Indication withdrawal
April 30, 2026 - The FDA approved the indication withdrawal of Karyopharm Therapeutics’ Xpovio (selinexor), for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
Drug Approvals
Evdi (trabectedin) – New drug approval
May 1, 2026 - The FDA approved Apotex’s Evdi (trabectedin), for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
Drug Recalls - Availability
Neurocrine Biosciences – Discontinuation of Crenessity™ (crinecerfont) 25 mg capsule
April 28, 2026 - Neurocrine Biosciences announced a business decision to discontinue Crenessity (crinecerfont) 25 mg capsules. Crenessity is not being discontinued for reasons of safety or effectiveness.
Drug Recalls - Availability
Journey Medical Corporation – Discontinuation of Exelderm™ (sulconazole) 1% topical solution
May 8, 2026 - Journey Medical Corporation announced a business decision to discontinue Exelderm (sulconazole) 1% topical solution. Exelderm is not being discontinued for reasons of safety or effectiveness.
New Generics
Astagraf XL® (tacrolimus) – First-time generic
May 4, 2026 - Amneal launched an AB-rated generic version of Astellas’ Astagraf XL (tacrolimus) extended-release capsules.