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
FDA Clearance To Initiate Ph 1/2 Clinical with TTX-MC138 in Advanced Solid Tumors Announced April 16, 2024
FDA accepts NDA for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers April 16, 2024
Datopotamab deruxtecan BLA accepted in the US for patients with previously treated metastatic HR+ve, HER2-neg breast cancer April 8, 2024
Pluvicto® pre-taxane label expansion filing planned in H2 2024 based on latest data from Ph 3 PSMAfore study April 8, 2024
Zanidatamab BLA for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer initiated April 8, 2024
Supplemental NDA for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients approved April 8, 2024
China’s NMPA Accepts Supplemental BLA for enfortumab vedotin with KEYTRUDA for 1L Bladder Cancer April 2, 2024
FDA Priority Review of NDA for Revumenib for the Treatment of R/R KMT2Ar Acute Leukemia April 2, 2024
Savolitinib Supplemental NDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC April 2, 2024
