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
NMPA approves trastuzumab botidotin (A166) for patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapy October 18, 2025
Libtayo® (cemiplimab-rwlc) Approved in US for Adjuvant Treatment of CSCC with a High Risk of Recurrence After Surgery and Radiation October 15, 2025
FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer September 30, 2025
FDA Approves SC KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection Across Most Solid Tumor Indications for KEYTRUDA September 23, 2025
European Commission Approves VORANIGO® (vorasidenib) for Grade 2 IDH-Mutant Glioma September 23, 2025
