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...
Drug
Ascentage Pharma Highlights Hematology Advances at EHA 2025, Focus on Olverembatinib and APG-5918
China-based Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) unveiled 13 research presentations at the 2025 European...
Fosun Pharma’s Serplulimab Approved in Singapore and Malaysia for ES-SCLC Treatment
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its subsidiary Shanghai...
Changchun High-Tech Subsidiary Gains NMPA Approval for CINV Drug Trial
China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary...
Novo Nordisk Advances Amycretin for Weight Management in Phase III Trials
Denmark-based pharmaceutical major Novo Nordisk (NYSE: NVO) announced plans to advance both subcutaneous and oral...
FDA OKs MSD’s Keytruda for Perioperative Head and Neck Cancer Treatment With PD-L1 Expression
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that the US Food...
GSK Seeks EMA Approval to Expand RSV Vaccine Arexvy Use to Adults Aged 18+
UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that the European Medicines Agency (EMA)...
MSD Wins NMPA Approval for Keytruda-Lenvima Combo in Hepatocellular Carcinoma
US-based Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration...
Roche Imposes New Dosing Restrictions on Elevidys for Non-Ambulatory DMD Patients
Swiss pharmaceutical giant Roche AG (SWX: ROG, OTCMKTS: RHHBY) announced immediate new dosing restrictions for...
Innovent Biologics Initiates Phase III Trial for Mazdutide in OSA and Obesity
China-based Innovent Biologics, Inc. (HKG: 1801) announced the dosing of the first participant in China...
Abbisko Therapeutics Launches Clinical Study of FGFR4 Inhibitor in Advanced Hepatocellular Carcinoma
Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced the dosing of the first patient in...
AstraZeneca Launches Truqap in China for PIK3CA/AKT1/PTEN-Altered Breast Cancer
UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) announced the official commercial launch of Truqap (capivasertib) in...
AbbVie’s Mavyret Gains FDA Approval for Acute HCV in Children and Adults
US-based AbbVie (NYSE: ABBV) announced that the US Food and Drug Administration (FDA) has approved...
Zhaoke Ophthalmology’s TAB014 Receives BLA Review for wAMD Treatment
China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its Biologic License Application (BLA) for TAB014,...
Merck Launches Phase III Trial for Quadrivalent Dengue Vaccine V181
US-based Merck, Sharp & Dohme (MSD; NYSE: MRK) announced the launch of the Phase III...
Sanofi’s Rilzabrutinib Shows Promise in IgG4-Related Disease Trial
French pharmaceutical giant Sanofi (NASDAQ: SNY) announced positive results from a Phase II study of...
BeOne Medicines Wins FDA Approval for Brukinsa Tablet Across All Five Indications
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that it has received...
BMS Reports Positive POETYK PsA-1 Results for Sotyktu in Psoriatic Arthritis
US-based Bristol-Myers Squibb (BMS; NYSE: BMY) announced positive results from the pivotal Phase III POETYK...
Lilly Launches Mounjaro Multi-Dose Pen in China for Diabetes and Weight Management
US-based Eli Lilly & Co. (NYSE: LLY) announced the launch of Mounjaro (tirzepatide multi-dose prefilled...
ImmVira Commences Phase II Trial for MVR-T3011 in High-Risk NMIBC
Shenzhen-based ImmVira announced that it has administered the first patient dose in a global, multi-center...