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...
Drug
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...
Suzhou GenAssist’s GEN6050X Gains FDA Orphan Drug Status for Duchenne Muscular Dystrophy
China-based Suzhou GenAssist Therapeutic Co., Ltd. announced that its in vivo base editing therapy, GEN6050X,...
AbbVie’s Venclexta Fails to Meet Overall Survival Endpoint in HR-MDS Trial
US-based major AbbVie Inc., (NYSE: ABBV) has revealed disappointing data for its Venclexta (venetoclax) in...
Roche Advances Prasinezumab to Phase III for Early Parkinson’s Disease
Switzerland-based Roche (SWX: ROG, OTCMKTS: RHHBY) announced its decision to advance prasinezumab, an anti-α-synuclein antibody...
Pediatrix Therapeutics Wins Macau Approval for Neffy Epinephrine Nasal Spray
China-based Pediatrix Therapeutics announced that it has received marketing approval in Macau for its neffy...
Minova Pharmaceuticals Launches Rongzhi, China’s First Injectable Adipocytolytic Drug
Nanjing-based Minova Pharmaceuticals Co., Ltd announced last week that it has received marketing approval from...
Fujian Cosunter Gains Ethics Approval for Phase III Study of Neracorvir in CHB Patients
China-based Fujian Cosunter Pharmaceutical Co., Ltd. (SHE: 300436) announced that it has received ethical approval...
CDE Accepts NDA for Ark Bio’s Azstarys, a Priority-Reviewed ADHD Treatment
China’s Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for...