Everest Medicines’ Velsipity NDA Accepted in Macau, Poised for First Asian Approval
Everest Medicines (HKG: 1952), based in China, has announced that its New Drug Application (NDA)...
Market approval filings
Eli Lilly Delays Donanemab Action Date as FDA Calls for Advisory Committee Review
Eli Lilly (NYSE: LLY) has announced a delay in the action date for its Alzheimer’s...
Visen Pharmaceuticals’ TransCon hGH Accepted for Review by China’s NMPA
Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma and Chinese healthcare-focused investment firm Vivo...
EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson...
Hybio Pharmaceutical Gets FDA Nod for Liraglutide Raw Materials with DMF Adequacy Letter
Hybio Pharmaceutical Co., Ltd (SHE: 300199), a China-based pharmaceutical company, has announced that it has...
EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug...
Aosaikang’s Marketing Approval Filing for Delafloxacin Accepted by China’s NMPA
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the...
Huadong Medicine’s Arcalyst Filing for Recurrent Pericarditis Accepted by China’s NMPA
Huadong Medicine Co., Ltd, (SHE: 000963) a Chinese pharmaceutical company, has announced that the National...
Innovent Biologics’ Taletrectinib Receives Second NDA Acceptance in China for ROS1 Positive NSCLC
Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the...
AIM Vaccine Advances Pneumococcal Vaccine and Initiates Phase II Meningococcal Study
AIM Vaccine Co., Ltd (HKG: 6660) has delivered a series of updates on the development...
Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National...
Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center...
CanSino Biologics’ 13-Valent Pneumococcal Vaccine CRM197 Accepted for NMPA Review
CanSino Biologics Inc., (HKG: 6185), a leading Chinese biopharmaceutical company, has announced that the National...
BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for...
Sanofi’s Dupixent Receives FDA Priority Review for COPD Indication Extension
Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food...
Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
This week, the U.S. FDA granted priority review status to an indication extension filing from...
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;...
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...
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...
Shanghai Junshi Biosciences’ Toripalimab Aims for Singapore Approval in Nasopharyngeal Carcinoma
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in...