FDA clears IND application for BA3361, a CAB-Nectin-4 Antibody Drug Conjugate for the Treatment of Multiple Tumors May 14, 2024
China NMPA Grants IND Clearance for ADRX-0706, a Novel Nectin-4 ADC for the Treatment of Advanced Solid Tumors May 14, 2024
US FDA accepts for priority review Supplemental BLA of Jemperli (dostarlimab) + chemo to include all adult patients with primary advanced or recurrent endometrial cancer May 1, 2024
FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Previously-treated Patients with Metastatic or Locally Advanced Biliary Tract Tumors May 1, 2024
FDA Approves GFH925 (KRAS G12C Inhibitor) Monotherapy trial in Ph 3 Registrational Study Treating Metastatic CRC May 1, 2024
FDA Clears IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors May 1, 2024
Feedback from FDA following Type B meeting encourages clinical development of rupitasertib in advanced breast cancer May 1, 2024
Positive CHMP opinion for RYBREVANT (amivantamab) in combination with chemotherapy for the 1L treatment of patients with advanced NSCLC with activating EGFR exon 20 insertion mutations May 1, 2024
CHMP Adopts Positive Opinion Recommending Approval of Opdivo in Combination with Cisplatin and Gemcitabine for the 1L Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma May 1, 2024
Ph 2/3 pivotal trial design and protocol for HB-200 + Keytruda in 1L HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC) aligned with FDA feedback May 1, 2024
Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER-positive breast cancer May 1, 2024
FDA Orphan Drug Designation and completion of FDA INTERACT meeting for BVX001 in the treatment of AML announced April 23, 2024
IND Application for the Clinical Trial of HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the 1L Treatment of Locally Advanced or Metastatic HCC Patients Approved by NMPA April 23, 2024
Type C Meeting Requested to FDA Toward Registration-Enabling Trial for Pelareorep in Breast Cancer April 16, 2024
Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression April 16, 2024
