Daiichi Sankyo and AstraZeneca Submit Enhertu Application for HER2-Positive Gastric Cancer in China
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have submitted a supplemental new-drug application...
Drug
Hainan Boao Research Hospital Secures Approval for China’s First Medical-Food Import for Rare Metabolic Disorders
Hainan Boao Research Hospital, operated by Shanghai’s Ruijin Hospital, has obtained provincial approval to import...
Sanofi’s Gene Therapy SAR446597 Secures FDA Fast Track for Geographic Atrophy
France-based Sanofi (NASDAQ: SNY) announced that its one-time intravitreal gene therapy SAR446597 has received FDA...
Hengrui Pharma and Kailera Announce Positive Phase III Results for HRS9531 in Obesity Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) and its US partner Kailera Therapeutics, Inc....
Haisco Pharma Receives FDA Approval for Clinical Trials of Autoimmune Drug HSK47388
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that it has received clinical trial...
AstraZeneca’s Baxdrostat Meets Primary and Secondary Endpoints in Phase III BaxHTN Trial
UK-based AstraZeneca (AZ, NASDAQ: AZN) announced that baxdrostat has achieved both primary and secondary endpoints in the...
Vigonvita’s Simenafil Receives NMPA Approval for Erectile Dysfunction Treatment
Suzhou-based Vigonvita Life Sciences Co., Ltd., announced that it has received marketing approval from the...
Huadong Medicine Receives FDA Approval for Clinical Trials of Innovative ADC HDM2020
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval...
Merck Initiates EXPrESSIVE Phase III Trial for Once-Monthly HIV PrEP Drug MK-8527
Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) announced the initiation of the EXPrESSIVE Phase...
China Medical System’s CMS-D001 Gains NMPA Approval for Atopic Dermatitis Trials
China Medical System Holdings Limited (CMS; HKG: 0867) announced that it has received clinical trial...
SinoMab BioScience Voluntarily Withdraws BLA for Suciraslimab in China Citing Need for Additional Data
SinoMab BioScience Ltd (HKG: 3681) announced the voluntary withdrawal of its Biologics License Application (BLA)...
Shanghai Henlius Biotech Initiates US Patient Dosing in Phase III Trial for HER2-Positive Gastric Cancer
China-based Shanghai Henlius Biotech Inc., (HKG: 2696) announced the first patient dosing in the US...
Bayer AG’s Kerendia Approved by FDA to Treat Adult Heart Failure with Ejection Fraction ≥40%
German pharmaceutical giant Bayer AG (ETR: BAYN) announced that it has received marketing approval from...
Sichuan Biokin’s Iza-bren Approved for Phase II Clinical Study in Renal Cell Carcinoma
China’s Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has received approval from the National Medical...
GSK’s Arexvy RSV Vaccine Expansion for Adults 18-49 Receives FDA Review
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has...
Boao Super Hospital Introduces Xiaflex for Non-Surgical Peyronie’s Disease Treatment
Boao Super Hospital in Hainan last week successfully introduced Xiaflex (collagenase clostridium histolyticum), a nonsurgical...
Eolas Therapeutics Gains Full Rights to AZD4041 for Opioid Use Disorder Development
US-based Eolas Therapeutics has entered into an agreement with its UK partner AstraZeneca (AZ, NASDAQ:...
YolTech Therapeutics Receives NMPA Clearance for YOLT-101 in HeFH Clinical Study
Shanghai-based YolTech Therapeutics announced that it has received clearance from the National Medical Products Administration...
InnoCare Pharma Receives FDA Approval for Mesutoclax in Myeloid Malignancies
Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received clinical trial...
Pfizer and Astellas’ Xtandi Shows Positive Results in Phase III EMBARK Study for Prostate Cancer
Partners Pfizer (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced positive topline results from...