NDA Submitted to the U.S. FDA for Sunvozertinib in Treating R/R NSCLC with EGFR Exon 20 Insertion Mutations November 12, 2024
FDA Regenerative Medicine Advanced Therapy (RMAT) Designation granted to ALLO-316 for Adult Patients with Advanced or Metastatic RCC November 5, 2024
Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer Completed November 5, 2024
FDA clearance to commence Ph 2 trial of leronlimab in patients with R/R microsatellite stable CRC November 5, 2024
IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Ph 1 Study in MSI-High Solid Tumors Announced November 5, 2024
FDA Clears IND Application for ATX-559 Ph 1 study in solid tumor patients with a focus on BRCA1/2-deficient breast cancer and MSI-H and dMMR solid tumors October 29, 2024
FDA’s Oncologic Drugs Advisory Committee Decision on use of Multikine® in PD-L1 Negative Cancer Patients announced October 29, 2024
FDA accepts NDA for UGN-102 (mitomycin) for intravesical solution for the treatment of LG-IR-NMIBC; PDUFA goal date: Jun 2025 October 22, 2024
Positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer October 22, 2024
Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Ph 3 trial in patients with recurrence of prostate cancer October 22, 2024
US FDA issues Study May Proceed letter for the Pilot Study of Pidnarulex PD in Patients with Advanced Solid Tumors October 22, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric AML October 22, 2024
IND Application for Ph 3 Study of Neoadjuvant KN026 +Albumin-bound Docetaxel in Breast Cancer Approved October 22, 2024
Positive CHMP Opinions for TEVIMBRA® as a 1L Treatment for Advanced/Metastatic Gastric or GEJ Cancer and Esophageal Squamous Cell Carcinoma October 22, 2024
FDA Clears IND Application for Ph 1/2 ADCElerate-01 Trial of ADCE-D01 Trial in Patients with Metastatic and/or Unresectable Soft Tissue Sarcoma (STS) October 15, 2024
Type II variation application to the EMA for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients October 15, 2024
CRLs submitted to request lifting the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel and CT071 October 15, 2024
Enhertu granted Priority Review in the US for patients with HER2-low/ultralow metastatic breast cancer who received at least one line of endocrine therapy October 8, 2024
Supplemental BLA filed for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned October 8, 2024
FDA Clears IND Application for REC-1245, a RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma October 8, 2024
