Ph 3 SIERRA trial deemed inadequate to support BLA filing for Iomab-B; additional head-to-head RCT demonstrating OS benefit required August 22, 2024
FDA Clears IND Application for Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST) August 13, 2024
FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia August 13, 2024
FDA accepts Supplemental NDA for Cabozantinib for Patients with Advanced Neuroendocrine Tumors August 13, 2024
FDA grants “Study May Proceed” letter for the Ph 1/2 study of Silmitasertib (CX-4945) + chemo in children and young adults with R/R solid tumors August 13, 2024
Supplemental NDA of Opdivo – Yervoy Combo submitted in Japan to Expand the Use for Unresectable HCC August 13, 2024
PDUFA Action Date Extension Announced for Revumenib NDA for R/R KMT2Ar Acute Leukemia; new PDUFA action date: Dec 26, 2024 August 7, 2024
FDA Fast Track Designation Granted to Ozuriftamab Vedotin (CAB-ROR2-ADC) for Patients with Recurrent or Metastatic SCCHN August 7, 2024
Scemblix® Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML based on ASC4FIRST Ph 3 study data August 6, 2024
IND Application filed for First in Class Senolytic Immunotherapy SenoVax™ for Treatment of Advanced Lung Cancer August 6, 2024
FDA Clears IND Application for UB-VV111, a CD19 Directed in situ CAR-T for Heme Malignancies August 6, 2024
FDA Fast Track Designation Granted to Soquelitinib for Treatment of Patients with R/R PTCL August 6, 2024
FDA grants Orphan Drug Designation for Avutometinib and Defactinib for the Treatment of Pancreatic Cancer August 6, 2024
FDA Advisory Committee reviewed Imfinzi for treatment of resectable NSCLC based on AEGEAN Ph 3 trial results July 30, 2024
CHMP recommends RYBREVANT + chemo for the treatment of adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy July 30, 2024
FDA Accepts BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma July 30, 2024
FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to UCART22 product candidate for ALL Treatment July 30, 2024
Regulatory path forward for uproleselan in R/R AML would require an additional clinical trial July 30, 2024
