Fast Track Designation for IDE161, for Treatment of Pretreated, Platinum-Resistant Advanced or Metastatic Ovarian Cancer Patients with BRCA1/2 Mutations October 3, 2023
Fast Track Designation for IDE161 for the Treatment of Pretreated, Advanced or Metastatic HR+, HER2-, BRCA1/2 mutant Breast Cancer October 3, 2023
FDA grants Fast Track Designation to MYTX-011 for Patients with NSCLC with cMET Overexpression October 3, 2023
FDA Accepts for Priority Review Supplemental NDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC September 26, 2023
U.S. FDA Fast Track Designation for KT-333 for the Treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma September 26, 2023
FDA Grants Priority Review to KEYTRUDA + Concurrent ChemoRT as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer September 26, 2023
Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML September 19, 2023
Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced NSCLC September 19, 2023
Positive EU CHMP Opinion for KEYTRUDA as Adjuvant Treatment for Adults with NSCLC at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemo September 19, 2023
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
