FDA Approves BIZENGRI® (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ NSCLC Based on Safety and Efficacy Data From the eNRGy Study December 10, 2024
FDA Approves IMKELDI (imatinib) Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers December 4, 2024
Kisqali receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence December 4, 2024
European Commission Approves TEVIMBRA for 1L Treatment of Advanced/Metastatic ESCC and Gastric or GEJ Cancer December 3, 2024
FDA Approves Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer November 26, 2024
European Commission Approves ELAHERE® (mirvetuximab soravtansine) for the Treatment of Platinum-Resistant Ovarian Cancer November 19, 2024
UK MHRA approved toripalimab (LOQTORZI®)-chemo combos for the 1L treatment of metastatic NPC and unresectable advanced, recurrent, or metastatic ESCC November 19, 2024
FDA Approves Revuforj® (revumenib) for Adult and Pediatric Patients with R/R Acute Leukemia with a KMT2A Translocation November 19, 2024
FDA approved Danziten™ (nilotinib with no mealtime restrictions) in 1L Ph+ CP CML and imatinib-treated AP Ph+ CML November 16, 2024
FDA approved obecabtagene autoleucel (Aucatzyl) for adults with R/R B-cell precursor acute lymphoblastic leukemia (ALL) November 12, 2024
MHRA grants marketing authorisation for BALVERSA (erdafitinib) for PD-(L)1 inhibitor-treated adults with unresectable/metastatic urothelial carcinoma (UC) with FGFR3 alterations November 12, 2024
FDA approved Scemblix in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile November 5, 2024
DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the EC for patients with newly diagnosed multiple myeloma who are transplant-eligible October 29, 2024
KEYTRUDA + chemo approved in the EU for patients with primary advanced/recurrent endometrial carcinoma and + chemoRT for patients with Stage III-IVA locally advanced cervical cancer October 29, 2024
Accelerated approval for Trodelvy® (sacituzumab govitecan-hziy) for patients with locally advanced or metastatic urothelial cancer refractory to platinum-containing chemo and PD-1/PD-L1 inhibitor withdrawn October 22, 2024
VYLOY (zolbetuximab-clzb) Approved by US FDA for Treatment of Advanced Gastric and GEJ Cancer October 22, 2024
FDA Approves Perioperative Treatment of Neoadjuvant Opdivo and Chemo Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable NSCLC October 15, 2024
FDA approves Itovebi for advanced HR+ve, HER2-neg breast cancer with a PIK3CA mutation October 15, 2024
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC October 15, 2024
IV Opdivo Approved in Taiwan in Combination with Cisplatin & Gemcitabine for the 1L Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma October 15, 2024
US FDA Approves Perioperative Treatment of Neoadjuvant Opdivo and Chemo Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable NSCLC October 8, 2024
China NMPA approves Cadonilimab for First-Line Treatment of Gastric/GEJ Cancer in All-Comers Population October 8, 2024
EC approved toripalimab (LOQTORZI®) for the treatment of certain patients with mNPC and ESCC October 2, 2024
Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer October 2, 2024