FDA Filing Acceptance and Priority Review for TIBSOVO in the Treatment of IDH1-mutated R/R MDS announced August 23, 2023
Orphan Drug Designation Granted by the FDA to NXP800 for the Treatment of Cholangiocarcinoma August 23, 2023
U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation August 9, 2023
FDA sends CRL for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with R/R CTCL August 9, 2023
FDA Grants Fast Track designation to IVS-3001 for the Treatment of Renal Cell Carcinoma August 2, 2023
EMA Approves Clinical Trial Application (CTA) for AVC-201 for the Treatment of R/R AML and other CD123 Hematological Malignancies August 2, 2023
CHMP Positive Opinion for JZP458 for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma August 2, 2023
FDA clears IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for multiple myeloma August 2, 2023
Favorable IDMC Recommendation to Continue Ph 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer July 27, 2023
EMA provides negative Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced NSCLC with a KRAS G12C Mutation July 27, 2023
FDA accepts Filing of NDA for Rivoceranib + Camrelizumab as a First-line Treatment for Unresectable HCC July 27, 2023
Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with R/R DLBCL July 27, 2023
Positive EU CHMP Opinion for KEYTRUDA + Trastuzumab + Chemo as 1L Treatment for HER2-Positive Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1) July 27, 2023
Positive CHMP Opinions for TALVEY (talquetamab) and TECVAYLI (teclistamab) for the Treatment of Patients with R/R Multiple Myeloma July 27, 2023
Positive CHMP Opinion to ORSERDU® (Elacestrant) for ER+, HER2-, ESR1-mutated Locally Advanced or Metastatic Breast Cancer patients July 22, 2023
FDA granted Fast Track Designation for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC) July 19, 2023
Supplemental NDA submitted to FDA for BRUKINSA + obinutuzumab in R/R follicular lymphoma July 19, 2023
FDA clears FDA INDA for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer July 19, 2023
