December 5, 2025
Clinical Updates
Imfinzi® (durvalumab) – New indication
November 25, 2025 - AstraZeneca announced the FDA approval of Imfinzi (durvalumab), in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single-agent Imfinzi, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Drug Approvals
Itvisma® (onasemnogene abeparvovec-brve) – New orphan drug approval
November 24, 2025 - The FDA announced the approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve), for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene.
Drug Approvals
Voyxact® (sibeprenlimab-szsi) – New drug approval
November 25, 2025 - The FDA approved Otsuka’s Voyxact (sibeprenlimab-szsi), to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
Drug Recalls - Availability
Abbott – Recall of FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors
November 24, 2025 - Abbott announced a consumer level recall of multiple lots of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors because the sensors may provide incorrect low glucose readings.
New Generics
Gleostine® (lomustine) – First-time generic
November 20, 2025, - Carnegie launched an AB-rated generic version of NextSource Biotechnology’s Gleostine (lomustine) capsules.
New Generics
Mavenclad® (cladribine) – First-time generic
November 25, 2025 - Teva launched an AB-rated generic version of Serono’s Mavenclad (cladribine) tablets.