FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL)...
Cancer
Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the...
HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National...
Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for...
Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan....
Menarini Group Partners with VisualDx to Enhance BPDCN Identification Using AI/ML Tools
Italy’s Menarini Group, through its subsidiary Stemline Therapeutics Inc., has formed a partnership with US-based...
Junshi Biosciences Receives NMPA Approval for JS212 in Advanced Solid Tumors
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced receiving clearance from the...
Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22
On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received...
Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment
On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class...
Servier and Black Diamond Therapeutics Ink Global Deal for BDTX-4933
French pharmaceutical company Servier and US-based Black Diamond Therapeutics, Inc. (NASDAQ: BDTX) announced a strategic...
AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer
UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for...
Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-6213 in Solid Tumor Diagnosis
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clearance from the National Medical...
Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical...
AstraZeneca Licenses Alteogen’s ALT-B4 for Subcutaneous Cancer Therapies
UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has entered into a licensing agreement with South Korea-headquartered...
ROBO Medical’s Innovative Gastrointestinal Endoscopic Instrument Gains NMPA Approval
China’s National Medical Products Administration (NMPA) has approved ROBO Medical’s gastrointestinal endoscopic surgical instrument control...
Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products...
BioCity and MSD Enter Clinical Collaboration for BC3195 and Keytruda Combination Trial
China-based BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration agreement with US-based giant Merck, Sharp...
CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and...
Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for...
MindRank Ltd Receives FDA Clearance for MRANK-106 Clinical Study in Solid Tumors
China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced receiving clearance from the US Food...