Orphan Drug Designation Granted by US FDA for IO-202 (Anti-LILRB4) for the Treatment of Chronic Myelomonocytic Leukemia (CMML) February 26, 2024
Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed R/R Multiple Myeloma January 31, 2024
BLA accepted for obecabtagene autoleucel (obe-cel) as a potential treatment for R/R Adult B-cell ALL January 31, 2024
Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant NSCLC January 23, 2024
Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML) January 23, 2024
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
