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)...
PD-1/L1
Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the...
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...
HutchMed and Innovent Announce Positive Results for Fruquintinib and Sintilimab in Renal Cell Carcinoma Trial
Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801)...
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...
AstraZeneca’s Imfinzi Approved by NMPA for Early-Stage NSCLC Treatment
UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for...
Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical...
Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved by EU for Hepatocellular Carcinoma
US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission...
CStone Pharmaceuticals and SteinCares Ink Licensing Deal for PD-L1 Inhibitor in Latin America
China-based CStone Pharmaceuticals (HKG: 2616) and Costa Rica-based drug maker and distributor SteinCares have entered...
BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change...
CStone Pharmaceuticals Doses First Patient in CS2009 Phase I Study for Solid Tumors
China-based CStone Pharmaceuticals (HKG: 2616) announced the first patient dosing in a global, multi-center Phase...
Innovent Biologics Doses First Patient in IBI363 Melanoma Study vs Keytruda
China-based Innovent Biologics, Inc. (HKG: 1801) announced the first patient dosing in the pivotal regulatory...
Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from...
Hengrui Pharmaceuticals Gets NMPA Green Light for SHR-A2009 Study
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that the National Medical Products Administration...
Merck’s Keytruda sBLA for LA-HNSCC Accepted by FDA for Review
Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that the US Food and Drug...
Summit Therapeutics and Pfizer Collaborate on Ivonescimab-ADC Combo for Solid Tumors
Summit Therapeutics Inc. (NASDAQ: SMMT), the U.S. partner of China-based Akeso Inc. (HKG: 9926) for...
Bristol-Myers Squibb’s Opdivo-Yervoy Combo Nears FDA Approval for MSI-H Colorectal Cancer
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the U.S. FDA has accepted its filing for...
Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National...
Roche’s Tecentriq Wins Japan Approval for Alveolar Soft Part Sarcoma
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) and its Japanese partner Chugai Pharmaceutical Co.,...
Bristol-Myers Squibb’s Opdivo Shows Survival Benefit in CheckMate-816 Study
Bristol-Myers Squibb (BMS, NYSE: BMY) announced the final analysis of overall survival (OS) data from...