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
FDA Clearance obtained for a First in Human Clinical Study for Stage III/IV Ovarian Cancer Treatment with Autologous Vaccine Therapy, Innocell™ March 12, 2024
IMBRUVICA® (ibrutinib) Label expanded in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications March 12, 2024
Application submitted to the EMA for DARZALEX® (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma March 12, 2024
Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous NSCLC or HR+, HER2 Negative Breast Cancer March 12, 2024
Positive CHMP Opinion for CARVYKTI in Patients with Relapsed and Lenalidomide-Refractory Multiple Myeloma in Earlier Lines of Therapy March 5, 2024
U.S. FDA Breakthrough Therapy Designation for BAY 2927088 for NSCLC Harboring HER2 Activating Mutations March 5, 2024
