DARZALEX FASPRO®-based quadruplet regimen approved in the US for 1L transplant-ineligible multiple myeloma patients February 1, 2026
NMPA approves TABOSUN + TYVYT combo for the neoadjuvant treatment of patients with stage IIB-III resectable MSI-H/dMMR colon cancer January 4, 2026
Japan’s MHLW approves Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with 2L+ FL December 30, 2025
US FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and LAZCLUZE® (lazertinib) combo for 1L EGFRm NSCLC December 22, 2025
ENHERTU Plus Pertuzumab Approved in the US for Patients with 1L HER2 Positive Metastatic Breast Cancer December 22, 2025
FDA approves AKEEGA® for BRCA2m metastatic CSPC with 54% reduction in disease progression vs SOC December 15, 2025
FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced CSCC December 9, 2025
FDA approves expanded indication for Jaypirca (pirtobrutinib) for adults with R/R CLL/SLL previously treated with a covalent BTK inhibitor December 9, 2025
European Commission (EC) grants approval to Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with R/R, BTK inhibitor-treated MCL December 2, 2025
Imfinzi approved in the US as perioperative immunotherapy for patients with early gastric/GEJ cancers December 2, 2025
Swiss medical authority approves Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) combination as 1L maintenance therapy for ES-SCLC December 2, 2025
FDA grants accelerated approval to HYRNUO™ (sevabertinib) for patients with previously treated advanced HER2-mutant NSCLC November 24, 2025
European Commission Approves Subcutaneous Administration of KEYTRUDA® for All Adult Indications Approved in the European Union November 24, 2025
FDA Approves KEYTRUDA® and KEYTRUDA QLEX™ (berahyaluronidase alfa-pmph formulation), Each with Padcev®, as Perioperative Treatment for Adults with Cisplatin-Ineligible MIBC November 24, 2025
FDA approves EPKINLY® (epcoritamab-bysp), Rituximab and Lenalidomide combo for the Treatment of R/R Follicular Lymphoma November 24, 2025
DARZALEX FASPRO® approved by FDA for patients with high-risk smoldering multiple myeloma November 10, 2025
EC Approves KEYTRUDA as Part of Treatment Regimen for Adults with Resectable LA-HNSCC Expressing PD-L1 November 4, 2025
FDA Approves Revuforj® (revumenib) in Adult & Pediatric Patients with R/R NPM1 Mutated AML October 29, 2025
