FDA Acceptance and Priority Review of NDA for Avutometinib + Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer Announced January 7, 2025
NDA submitted to US FDA for Accelerated Approval for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma January 7, 2025
US FDA Accepts for Priority Review NDA for Taletrectinib for the Treatment of Advanced ROS1+ve NSCLC December 31, 2024
Datopotamab Deruxtecan Application in the EU for Patients with Advanced non-sqNSCLC Voluntarily Withdrawn December 31, 2024
FDA issues CRL for BLA for fixed combination of amivantamab and human hyaluronidase for SC amivantamab in patients with NSCLC with EGFR mutations December 26, 2024
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for 2L Treatment of ES-SCLC December 26, 2024
Type II variation application submitted to the EMA seeking approval of IMBRUVICA in adult patients with 1L MCL eligible for auto SCT December 25, 2024
U.S. FDA Fast Track Designation for NX-5948 for the Treatment of R/R Waldenstrom’s Macroglobulinemia December 25, 2024
Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer Announced December 25, 2024
Jemperli (dostarlimab-gxly) receives US FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer December 18, 2024
Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of VHL Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced RCC December 18, 2024
NDA for Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma to be submitted Before Year-End December 18, 2024
Jemperli (dostarlimab) + chemo receives positive CHMP opinion to expand approval to all adult patients with primary advanced or recurrent endometrial cancer December 18, 2024
FDA Clearance received to Administer AIV001 in Facial Skin by Intradermal Injection for Superficial and Nodular Superficial Basal Cell Carcinoma (sBCC and nBCC) December 18, 2024
FDA accepts IND application for initiation of a Ph 1 clinical trial to evaluate LNCB74 in multiple cancers December 18, 2024
Orphan Drug Designation from FDA for PLT012 in Treatment of Liver and Intrahepatic Bile Duct Cancer December 17, 2024
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated NSCLC December 10, 2024
Blenrep (belantamab mafodotin) combination accepted for priority review in China in R/R multiple myeloma December 10, 2024
Regulatory Update Related to Supplemental NDA for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced NETs provided December 10, 2024
