FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO:...
Drug
Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche...
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...
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...