TIVDAK® Supplemental BLA Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer January 17, 2024
Update on Zolbetuximab Biologics License Application in U.S.: FDA rejects the application January 17, 2024
FDA Issued New Postmarketing Requirement on Supplemental NDA seeking full approval of LUMAKRAS® (sotorasib) January 10, 2024
Rinatabart Sesutecan FDA Fast Track Designation for Patients with Advanced Ovarian Cancer January 10, 2024
FDA Clears IND Application for SENTI-202 for the Treatment of R/R Hematologic Malignancies Including AML January 4, 2024
Supplemental BLA and NDA submitted for RYBREVANT® (amivantamab-vmjw) + Lazertinib for the Treatment of Patients with EGFR-Mutated NSCLC January 4, 2024
U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer January 4, 2024
EMA confirms recommendation for non-renewal of authorisation of multiple myeloma medicine Blenrep January 4, 2024
FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer January 4, 2024
Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated NSCLC January 4, 2024
FDA guides on the next Ph 2 study for advancement of Next Generation Capecitabine (“NGC-Cap”) for cancer patients December 19, 2023
Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma December 19, 2023
Application submitted to the EMA for RYBREVANT + Chemo for the Treatment of Adult Patients with Advanced EGFR-Mutated NSCLC After Failure of Prior Therapy December 11, 2023
FDA Grants Priority Review of Supplemental BLA for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer December 11, 2023
Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer December 11, 2023
TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer December 11, 2023
