NMPA approves IND application for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma April 2, 2024
Stenoparib development Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer Accelerated April 2, 2024
PT886 granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma by the FDA March 26, 2024
Positive CHMP Opinion Received for XTANDI in Additional Recurrent Early Prostate Cancer Treatment Setting March 26, 2024
FDA issued CRLs for the BLAs for odronextamab in R/R follicular lymphoma (FL) and in R/R DLBCL, each after two or more lines of systemic therapy March 26, 2024
FDA ODAC recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with R/R multiple myeloma March 26, 2024
FDA Accepts BLA Resubmission Of LYMPHIR™ (Denileukin Diftitox) For The Treatment Of Adults With R/R Cutaneous T-Cell Lymphoma March 26, 2024
FDA Allows to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer March 26, 2024
FDA Advisory Committee Votes in Favor of Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy March 19, 2024
Orphan Drug Designation Granted to TERN-701 for the Treatment of Chronic Myeloid Leukemia March 19, 2024
Global Ph 3 Clinical Trial for Cholangiocarcinoma Authorized in the EU and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by EMA March 19, 2024
FDA clears INDs for CX-2051, a Probody® Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a Conditionally Activated Interferon Alpha-2b March 19, 2024
Rolling NDA submitted to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission March 19, 2024
MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment March 19, 2024
FDA Orphan Drug Designation Granted to P-BCMA-ALLO1 for the Treatment of Multiple Myeloma March 19, 2024
FDA accepts the NDA for ensartinib for the treatment of adult patients with metastatic ALK-positive NSCLC March 19, 2024
Global Ph 3 Trial for Cholangiocarcinoma Authorized in the EU and Orphan Drug Designation for Tinengotinib Granted by EMA March 12, 2024
Orphan Drug Designation from FDA for Avutometinib Alone or in Combination With Defactinib in Recurrent Low-Grade Serous Ovarian Cancer March 12, 2024
China’s NMPA Accepted Second NDA for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer March 12, 2024
