Genor Biopharma Gains NMPA Approval for CDK4/6 Inhibitor Lerociclib in China
China’s Genor Biopharma Co., Ltd (HKG: 6998) announced that it has received marketing clearance from...
Drug
Innovent Biologics Doses First Patient in Phase III Psoriasis Trial for Picankibart
China-based Innovent Biologics, Inc. (HKG: 1801) announced the first subject dosing in a Phase III...
GSK Halts PIVOT-PO Trial Early as Tebipenem HBr Meets Efficacy Targets for cUTI
UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced the early termination of the pivotal Phase...
Amoytop Biotech Wins NMPA Approval for Weekly Inpegsomatropin in Pediatric Growth Deficiency
Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) announced that it has received marketing approval from...
Regend Therapeutics Gains NMPA Approval for Phase I/II Study of REGEND003 in Diabetes-Related CKD
Suzhou-based stem cell therapy specialist Regend Therapeutics announced that it has received approval from China’s...
BMS Gains European Approval for Opdivo Subcutaneous Formulation
Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the European Commission (EC) has granted approval to...
Novartis’ Fabhalta Approved for Previously Treated PNH Patients in China
The China unit of Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that the National Medical...
InnoCare Pharma Gains NMPA Clinical Approval for BCL2 Inhibitor ICP-248
Beijing-headquartered biotech company InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received clinical...
Lupeng Pharma’s Rocbrutinib Near Approval for Mantle Cell Lymphoma
Guangzhou Lupeng Pharmaceutical Co., Ltd’s rocbrutinib is currently under New Drug Application (NDA) review at...
Bayer’s Sevabertinib Receives FDA Priority Review for HER2-mutant NSCLC
German pharmaceutical giant Bayer AG (ETR: BAYN) announced that its investigational oral small-molecule tyrosine kinase...
JW Therapeutics’ Carteyva Receives Fourth sBLA for r/r LBCL
JW Therapeutics (HKG: 2126), a clinical-stage cell therapy company co-founded in 2016 by Juno Therapeutics...
Changchun Pharma Wins FDA Approval for GenSci128 in TP53 Y220C Solid Tumors
China-based Changchun High & New Technology Industries (Group) Inc., (SHE:000661) announced that its subsidiary Changchun...
Yantai Dongcheng Pharma Gains NMPA Approval for Sodium Fluoride [18F]
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has received marketing approval from the...
RemeGen’s Telitacicept Approved for Myasthenia Gravis in China
China-based pharmaceutical firm RemeGen (HKG: 9995) announced the third indication approval from the National Medical...
Biogen and City Therapeutics Collaborate on RNAi Therapies for CNS Diseases
US-based Biogen Inc. (NASDAQ: BIIB) announced a strategic collaboration with compatriot firm City Therapeutics, Inc....
AstraZeneca’s Imfinzi Gets Positive Opinion for Bladder Cancer Perioperative Treatment
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that the European Medicines Agency’s (EMA) Committee...
EyePoint’s Partner Betta Completes Enrollment for Duravyu’s Pivotal Phase III Study
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), the US partner of China-based Betta Pharmaceuticals (SHE: 300558), announced...
EMA Recommends Tevimbra for Nasopharyngeal Cancer First-line Treatment
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
AbelZeta Pharma’s C-CAR168 Secures FDA RMAT Designation for Lupus Treatments
Sino-US biotech AbelZeta Pharma, Inc., based in Rockville, Maryland, and with operations in Shanghai, announced...
CARsgen’s Satricabtagene Autoleucel Granted Priority Review by China’s CDE
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the Center for Drug Evaluation...