FDA Clearance To Initiate Ph 1/2 Clinical with TTX-MC138 in Advanced Solid Tumors Announced April 16, 2024
FDA accepts NDA for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers April 16, 2024
Datopotamab deruxtecan BLA accepted in the US for patients with previously treated metastatic HR+ve, HER2-neg breast cancer April 8, 2024
Pluvicto® pre-taxane label expansion filing planned in H2 2024 based on latest data from Ph 3 PSMAfore study April 8, 2024
Zanidatamab BLA for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer initiated April 8, 2024
Supplemental NDA for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients approved April 8, 2024
China’s NMPA Accepts Supplemental BLA for enfortumab vedotin with KEYTRUDA for 1L Bladder Cancer April 2, 2024
FDA Priority Review of NDA for Revumenib for the Treatment of R/R KMT2Ar Acute Leukemia April 2, 2024
Savolitinib Supplemental NDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC April 2, 2024
NMPA approves IND application for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma April 2, 2024
Stenoparib development Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer Accelerated April 2, 2024
PT886 granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma by the FDA March 26, 2024
Positive CHMP Opinion Received for XTANDI in Additional Recurrent Early Prostate Cancer Treatment Setting March 26, 2024
FDA issued CRLs for the BLAs for odronextamab in R/R follicular lymphoma (FL) and in R/R DLBCL, each after two or more lines of systemic therapy March 26, 2024
FDA ODAC recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with R/R multiple myeloma March 26, 2024
FDA Accepts BLA Resubmission Of LYMPHIR™ (Denileukin Diftitox) For The Treatment Of Adults With R/R Cutaneous T-Cell Lymphoma March 26, 2024
FDA Allows to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer March 26, 2024
FDA Advisory Committee Votes in Favor of Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy March 19, 2024
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
