FDA Grants Full Approval For Blincyto To Treat MRD-Positive B-Cell Precursor Acute Lymphoblastic Leukemia June 28, 2023
TALZENNA + XTANDI Combo Receives FDA Approval for adult patients with HRR-mutated metastatic CRPC June 28, 2023
FDA Approves FoundationOne®LiquidCDx as a Companion Diagnostic for BRAFTOVI + Cetuximab combo to Identify Patients With BRAF V600E Alterations in mCRC June 14, 2023
Lynparza + abiraterone approved in the US for the treatment of BRCA-mutated metastatic CRPC June 6, 2023
VANFLYTA First FLT3 Inhibitor Approved in Japan for Patients with Newly Diagnosed FLT3-ITD Positive AML May 31, 2023
The China NMPA Approves TYVYT® + Bevacizumab + Chemotherapy in Patients with EGFR-mutated nsqNSCLC who Progressed after EGFR-TKI Therapy May 18, 2023
European Commission approves Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma May 18, 2023
European Commission granted approval to AKEEGA® (Niraparib & Abiraterone Dual Action Tablet) for the Treatment of Patients with metastatic CRPC with BRCA1/2 Mutations May 10, 2023
FDA approves Polivy in combination with R-CHP for people with certain types of 1L DLBCL April 27, 2023
FDA Approves KEYTRUDA + Padcev combination for 1L Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer April 12, 2023
FDA Converts to Full Approval Indication for KEYTRUDA® for Certain Adult and Pediatric Patients With Advanced MSI-H or dMMR Solid Tumors April 6, 2023
Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma March 31, 2023
Imfinzi plus Imjudo approved in the EU for patients with 1L HCC and mNSCLC based on significant survival benefits in HIMALAYA and POSEIDON Ph 3 trials February 28, 2023
NMPA grants Tislelizumab + chemo approval for 1L use in advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression February 28, 2023
Enhertu approved in China for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens February 28, 2023
UK MHRA grants full Marketing Authorization to NEXPOVIO (selinexor), Velcade, and SVd combo for previously-treated multiple myeloma patients February 22, 2023
US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer February 22, 2023