MAA submitted to the EMA for Approval of Erdafitinib in Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations September 14, 2023
ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers September 6, 2023
Supplemental NDA submitted to FDA for Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma September 6, 2023
FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence September 6, 2023
Supplemental BLA submitted to FDA for RYBREVANT® (amivantamab-vmjw) + Chemo for 1L EGFR Exon 20 Insertion Mutation-Positive mNSCLC September 6, 2023
Supplemental NDA submitted to FDA for Full Approval of BALVERSA for the Treatment of Patients with Locally Advanced/Met Urothelial Carcinoma with Selected FGFR Gene Alterations September 6, 2023
Application For Lumakras® (Sotorasib) For The Treatment Of KRAS G12C-Positive NSCLC To be Discussed At FDA Advisory Committee Meeting September 6, 2023
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
