December 12, 2025
Clinical Updates
Breyanzi® (lisocabtagene maraleucel) – New indication
December 4, 2025 - Bristol Myers Squibb announced the FDA approval of Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.
Clinical Updates
Jaypirca® (pirtobrutinib) – Expanded indication, accelerated approval converted to traditional approval
December 3, 2025 - Eli Lilly announced the FDA traditional approval of Jaypirca (pirtobrutinib), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
New Generics
Adzenys XR-ODT® (amphetamine) – First-time generic
December 8, 2025, - Teva launched an AB-rated generic version of Aytu BioPharma’s Adzenys XR-ODT (amphetamine) orally disintegrating extended-release tablets.
New Generics
Cipro HC® (ciprofloxacin/hydrocortisone) – First-time generic
November 24, 2025 - Cosette launched an AB-rated generic version of Sandoz’s Cipro HC (ciprofloxacin/hydrocortisone) otic suspension.