Ph 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of OS and PFS in Certain Patients With 1L Locally Advanced or Metastatic Urothelial Cancer September 26, 2023
FDA Accepts for Priority Review Supplemental NDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC September 26, 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
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
Tecentriq subcutaneous (SC) is approved in Great Britain for all indications of IV Tecentriq, offering a faster, more convenient option to receive treatment September 6, 2023
Positive Results from Ph 3 CONTACT-02 Trial of Cabozantinib + Atezolizumab in metastatic CRPC Announced 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 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
Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darolutamide) for Planned Phase 1b/2 Clinical Trial September 1, 2023
First participant of cohort 3 in theranostic SECuRE trial of 64Cu/67Cu SAR-bisPSMA in metastatic CRPC treated at the highest dose level of 12GBq September 1, 2023
Lynparza + abiraterone approved in Japan for the treatment of BRCA-mutated metastatic CRPC September 1, 2023
WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of PFS in Certain Previously Treated Patients With Advanced RCC August 23, 2023
FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate) for Treatment of Patients with BRCA+ve metastatic CRPC August 16, 2023
CG Oncology Announces $105 Million Oversubscribed Crossover Financing to Support Continued Advancement of Clinical-Stage Bladder Cancer Pipeline August 9, 2023
UGN-102 Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials in NMIBC patients August 2, 2023
FDA Grants Fast Track designation to IVS-3001 for the Treatment of Renal Cell Carcinoma August 2, 2023
Opdivo + Chemo Shows OS & PFS Benefit for Cisplatin-Eligible Patients with Unresectable or Metastatic Urothelial Carcinoma in the Phase 3 CheckMate -901 Trial July 19, 2023
Enrollment completed in Pivotal Phase 3 TiNivo-2 Study of FOTIVDA® (tivozanib) in Combination with OPDIVO® (nivolumab) in Advanced Renal Cell Carcinoma July 5, 2023
TALZENNA + XTANDI Combo Receives FDA Approval for adult patients with HRR-mutated metastatic CRPC June 28, 2023
Lynparza + abiraterone approved in the US for the treatment of BRCA-mutated metastatic CRPC June 6, 2023
KEYTRUDA + LENVIMA Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as 1L Treatment for Patients With Advanced RCC May 31, 2023
