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...
Allgens Medical’s SkuHeal Artificial Bone Repair Material Gains Vietnam Marketing Approval
Beijing-based regenerative medicine materials and implantable device maker Allgens Medical Technology Co., Ltd (SHA: 688613)...
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...
Shanghai Henlius Biotech Partners with Shanghai Chest Hospital for Clinical Research and Talent Development
China’s Shanghai Henlius Biotech Inc., (HKG: 2696) this week entered into a strategic collaboration agreement...
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...
Mindray Bio-Medical Expands North American Warehouse to Enhance Operational Efficiency
China-based Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (SHE: 300760) announced the groundbreaking of its North...
GSK Launches ‘Linked by Lupus’ Initiative to Support Lupus Care with $1M Funding
UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced the launch of the Linked by Lupus:...
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)...
EpimAb Biotherapeutics Submits Hong Kong IPO Application as Biotech Expands
Shanghai-based biotech EpimAb Biotherapeutics, Inc. has submitted a main board listing application to the Hong...
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...