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...
Drug
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...
Daiichi Sankyo Launches Phase I Trial for Enhertu Subcutaneous Formulation
Japan-based Daiichi Sankyo (TYO: 4568) has registered a Phase I clinical trial on ClinicalTrials.gov for...
Huadong Medicine Receives NMPA Approval for Phase III Trial of Roflumilast Foam
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that Its wholly-owned subsidiary Hangzhou Zhongmei Huadong...
China’s Sichuan Kelun-Biotech Wins BTD for Sac-TMT in Non-Squamous NSCLC
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that its core product Jiatailai (sacituzumab...
Henlius Biotech Starts Global Phase II Trial for PD-L1 ADC HLX43
China’s Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a global,...
Merck’s Pimicotinib NDA Accepted for Review by China’s CDE
German pharmaceutical major Merck KGaA (ETR: MRK) announced that the New Drug Application (NDA) for...