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
Positive feedback received from FDA on the planned TACTI-004 Ph 3 trial of eftilagimod alfa + KEYTRUDA + chemo for the treatment of 1L NSCLC July 30, 2024
Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA July 30, 2024
Ph 2 volasertib program receives “Clearance to Proceed” from the FDA and agreement on the dosing plan for Ph 2 clinical trial July 30, 2024
Positive EU CHMP Opinion for KEYTRUDA + Padcev as 1L Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma July 30, 2024
Update Provided from iSCIB1+ Clinical Advisory Meeting to Strengthen Plans for Ph 2/3 Registration Clinical Trial July 27, 2024
EMA validated Type II Application for Opdivo plus Yervoy for 1L Treatment of Unresectable or Advanced HCC July 23, 2024
