Roche Secures NMPA Approval for Rozlytrek to Treat Pediatric NTRK Fusion-Positive Tumors
Swiss pharmaceutical giant Roche (SWX: ROG) has received a new indication approval from the National...
Drug
FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK;...
CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical...
Evopoint Biosciences Enrolls First Patient in Phase III Trial for Gout Drug XNW3009
Suzhou-based Evopoint Biosciences Co., Ltd. has announced the enrollment of its first patient in a...
ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
Beijing-based ChinaGene Technology Co., Ltd. has announced that it has received tacit clinical approval from...
Nanjing Zenshine’s ZX-7101A NDA Accepted by NMPA for Uncomplicated Influenza Treatment
Nanjing Zenshine Pharmaceuticals Co., Ltd., a China-based small molecule drug developer, has announced that the...
Jiangsu Hengrui Receives NMPA Approval for Phase II Study of GLP-1 Agonist for Weight Loss
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Shanghai Procurement Platform Offers Price Cut Leeway to Escape ‘High-Priced Drugs’ Tag
Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) platform has announced a significant policy shift regarding non-winning...
BioNTech and Duality’s DB-1305 Earns Fast-Track Status for Platinum-Resistant Cancers
German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd...
MSD’s Keytruda Secures 13th Indication Approval in China for Biliary Carcinoma Treatment
Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that...
Konruns Pharmaceutical Commences Phase III Clinical Trial for KC1036 in Esophageal Cancer
Konruns Pharmaceutical Co., Ltd (SHA: 603590), a Beijing-based pharmaceutical company, has announced the first patient...
Joincare Pharmaceuticals Gets Green Light for Semaglutide Biosimilar Clinical Trial
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical entity, has announced that...
CSPC Pharmaceutical’s rhTNK-tPA Gets NMPA Approval for Acute Ischemic Stroke Treatment
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced...
Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific...
J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE:...
Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE:...
SciClone and Menarini File for Import License of Antibacterial Drug Vaborem in Macau
SciClone Pharmaceuticals Inc (HKG: 6600) has announced that its Italy-based strategic partner Menarini has submitted...
Biotech Pharmaceutical Secures Approval for Nimotuzumab in Head and Neck Cancer Treatment
Sino-Cuban joint venture Biotech Pharmaceutical Limited (BPL) has secured another indication approval in China for...
BMS Sees Mixed Results in 2023: Growth in New Products Offset by Loss of Exclusivity
Bristol Myers Squibb (BMS; NYSE: BMY) reported a 2% year-on-year contraction in 2023 revenues, excluding...
Chongqing Genrix Biopharmaceutical Gets NMPA Clearance for IL-4Rα mAb Candidate GR1802
Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443), a Chinese biopharmaceutical company, has announced that it...