October 10, 2025
Clinical Updates
COVID-19 and Measles, Mumps, Rubella and Varicella (MMRV) vaccines – CDC Director adopts ACIP recommendations
October 6, 2025 - The Centers for Disease Control and Prevention’s (CDC) Acting Director adopted the Advisory Committee on Immunization Practice’s (ACIP) recommendations for 2025 - 2026 COVID-19 vaccines and MMRV vaccines. The recommendations were as follows. COVID-19 immunization schedules for adults and children will be guided by individual-based decision-making. Children ages 12 months to three years should receive the varicella vaccine as a standalone immunization, rather than as part of the combined MMRV vaccine. Children in this age group should receive the MMR vaccine and varicella vaccine separately (MMR+V).
Clinical Updates
Tecentriq® (atezolizumab) or Tecentriq Hybreza® (atezolizumab/hyaluronidase-tqjs) plus Zepzelca® (lurbinectedin) – New indication
October 2, 2025 - Genentech and Jazz Pharmaceuticals announced the FDA approval of Tecentriq (atezolizumab) or Tecentriq Hybreza (atezolizumab/hyaluronidase-tqjs) plus Zepzelca (lurbinectedin), for maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide.
Clinical Updates
Zoryve® (roflumilast) – Expanded indication, new strength
October 6, 2025 - Arcutis Biotherapeutics announced the FDA approval of Zoryve (roflumilast) 0.05% cream, for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.
Drug Approvals
Eydenzelt® (aflibercept-boav) – New biosimilar approval
October 2, 2025 - Celltrion announced the FDA approval of Eydenzelt (aflibercept-boav), biosimilar to Regeneron’s Eylea® (aflibercept).
Drug Approvals
Jascayd® (nerandomilast) – New orphan drug approval
October 7, 2025 - The FDA announced the approval of Boehringer Ingelheim’s Jascayd (nerandomilast), for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients.
Drug Approvals
Qivigy® (immune globulin intravenous, human-kthm) – New drug approval
September 29, 2025 - Kedrion Biopharma announced the FDA approval of Qivigy (immune globulin intravenous, human-kthm), for the treatment of adults with primary humoral immunodeficiency (PI).
Drug Approvals
Rhapsido® (remibrutinib) – New drug approval
September 30, 2025 - Novartis announced the FDA approval of Rhapsido (remibrutinib), for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
Drug Recalls - Availability
Grifols – Withdrawal of Gamunex®-C (immune globulin [human]) 10% injection
October 1, 2025 - Grifols Therapeutics announced a voluntary, consumer level withdrawal of two lots of Gamunex-C (immune globulin [human]) 10% injection because of an increased rate of allergic/hypersensitivity type reactions.