MindRank’s MDR-001 Phase IIb Study Achieves Clinical Endpoints for Weight Loss
China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced that the multi-center, 24-week Phase IIb...
Drug
Eccogene Announces First Patient Dosing in Phase Ib Study of AZD5004/ECC5004 in China
Sino-US firm Eccogene Inc., a partner of UK major AstraZeneca (AZ, NASDAQ: AZN), announced the...
Simcere Zaiming Initiates US Phase I Study of SIM0500 for Relapsed/Refractory Multiple Myeloma
China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary Simcere Zaiming announced the first patient dosing...
FDA Launches ‘Elsa’ AI Tool to Enhance Staff Efficiency in Regulatory Processes
The U.S. Food and Drug Administration (FDA) announced the launch of an artificial intelligence (AI)...
FDA Launches Immediate Review of Clinical Trials Involving Cell Transfer to Hostile Countries
The U.S. Food and Drug Administration (FDA) this week announced an immediate review of new...
Gilead’s Yeztugo Approved by FDA as First Six-Monthly Injectable HIV PrEP
US-based Gilead Sciences, Inc. (NASDAQ: GILD) announced that it has received market approval from the...
Fosun Pharma’s Fumaining Launches Clinically for Rare Disease Treatment in China
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd.’s (HKG: 2196, SHA: 600196) in-house developed Category 1 drug...
FDA Launches Commissioner’s National Priority Voucher Program for Accelerated Drug Reviews
The U.S. Food and Drug Administration (FDA) this week announced the launch of the Commissioner’s...
Hengrui Pharma’s Ruitanning Enters Clinical Use for Chemo-Induced Nausea and Vomiting
China’s Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the prescription of its Category 1...
Merck’s Clesrovimab Gears Up for Priority Review in China for RSV Prevention
China’s Center for Drug Evaluation (CDE) website indicates that US giant Merck, Sharp & Dohme’s...
Sanofi’s Tzield Prescribed in Boao Lecheng to Delay Onset of Type 1 Diabetes
Tzield (teplizumab), the world’s first and only targeted therapy designed to delay the onset of...
Clover Biopharmaceuticals Completes Enrollment for Phase I Trial of RSV + hMPV Combination Vaccines
China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) announced the completion of enrollment for the first participants...
RemeGen’s Telitacicept Receives Orphan Drug Designation for Myasthenia Gravis in Europe
China-based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) announced that it has received orphan drug...
Yunnan Baiyao’s JZ-14 Gets NMPA Clinical Clearance for Ulcerative Colitis Trial
Kunming-based Yunnan Baiyao Group Co., Ltd (SHE: 000538), traditionally known for Chinese medicine, announced clinical...
Johnson & Johnson Submits sBLA to Expand Stelara Use for Pediatric Crohn’s Disease
US giant Johnson & Johnson (J&J, NYSE: JNJ) this week submitted a supplemental Biologics License...
Suzhou Zelgen Gains NMPA Approval for ZG005 and ZG006 Combination Trial in Advanced Cancers
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial...
Bayer Files NDA for Gadoquatrane, Aiming to Offer Lowest-Dose GBCA in the U.S.
Germany-based Bayer AG (ETR: BAYN) announced that it has made a New Drug Application (NDA)...
Sinocelltech Gains NMPA Clearance for SCTB39-1 Clinical Study in Advanced Solid Tumors
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received clearance from the National...
Santen’s Ryjunea Gets EU Approval to Slow Myopia Progression in Children
Japan-based Santen Pharmaceutical Co., Ltd. announced that it has received marketing approval from the European...
Sino Biopharmaceutical’s TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been...