BLAs for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R LBCL and DLBCL submitted November 2, 2022
U.S. FDA Accepts For Priority Review Supplemental BLA For Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer October 19, 2022
US FDA grants Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with LUMAKRAS® (sotorasib) October 19, 2022
Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option Announced October 19, 2022
FDA grants Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for 1L NSCLC October 12, 2022
FDA grants Fast Track Designation for Sapanisertib in NRF2-mutated Squamous Lung Cancer October 12, 2022
Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA® October 12, 2022
TUKYSA® (tucatinib) + Trastuzumab combo Granted Priority Review by FDA for Previously Treated HER2+ve Metastatic CRC September 28, 2022
Applications Submitted For Rubraca® Label Expansion In The US And EU As 1L Maintenance Treatment In Advanced Ovarian Cancer Patients September 28, 2022
Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults with MZL September 28, 2022
Yescarta® Gets Positive CHMP Opinion For Use In 2L DLBCL And High-Grade B-Cell Lymphoma September 28, 2022
Oncologic Drugs Advisory Committee to review Zejula overall survival data from the NOVA Ph 3 trial in recurrent ovarian cancer September 28, 2022
IND Application submitted to the FDA for Ph 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations September 7, 2022
EMA Grants Orphan Drug Designation to Cornerstone Pharmaceuticals’ CPI-613® (Devimistat) for Treatment of Patients with Advanced Unresectable Biliary Tract Cancer June 14, 2022
Elevation Oncology Announces FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene Fusions June 14, 2022
MHRA and Research Ethics Committee Approvals Received to Initiate Ph 2B/3 AML Trials of OmnImmune March 24, 2022
FDA Clearance to Proceed with Ph 1b/2 Trial of ADG126 SAFEbody® in Combination with Pembrolizumab Announced March 17, 2022
FDA Clears IND for Phase 1b/2 Trial of ADG116 in Combination with Pembrolizumab in Patients with Solid Tumors November 30, 2021
