FDA accepted for Priority Review the BLA for linvoseltamab for R/R multiple myeloma that has progressed after at least three prior therapies February 26, 2024
FDA accepts Supplemental NDA for KRAZATI® (adagrasib) – Cetuximab combo for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or mCRC February 26, 2024
Positive EU CHMP Opinion for KEYTRUDA in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence February 26, 2024
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
