SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted...
Drug
Bayer’s Asklepios BioPharmaceutical Launches Phase II Trial for AAV Therapy in Heart Failure
Bayer’s (ETR: BAYN) gene therapy subsidiary, Asklepios BioPharmaceutical, has initiated patient recruitment for a Phase...
CanSino Biologics Enrolls First Patient in Phase I Trial of Innovative Polio Vaccine
CanSino Biologics (SHA: 688185, HKG: 6185), a China-based biotechnology firm, has announced the enrollment of...
RemeGen Secures Fast-Track Designation for RC88 in Platinum-Resistant Ovarian Cancer
China-based biotech RemeGen Co., Ltd (HKG: 9995; SHA: 688331) has received fast-track designation (FTD) from...
CSPC Pharmaceutical Secures FDA Approval for Clinical Study of JMT106 in GPC3-Positive Tumors
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received approval from the US FDA to...
MSD’s Keytruda Gains FDA Approval for Advanced Cervical Cancer Treatment
Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food...
BMS’s Mavacamten Used to Treat First Patient with Hypertrophic Cardiomyopathy in Hainan
Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that the first patient with obstructive hypertrophic cardiomyopathy...
CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that it has received approval from...
Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501
Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from...
Huadong Medicine’s Relmapirazin Approval Filing Accepted by NMPA for GFR Measurement
Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that its market approval...
Novo Nordisk’s IcoSema Shows Promise in Late-Stage Trial for Type 2 Diabetes Management
Danish pharmaceutical giant Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial...
AbbVie’s Lutikizumab Advances to Phase III for Hidradenitis Suppurativa After Positive Mid-Stage Results
AbbVie (NYSE: ABBV) has announced the progression of lutikizumab to Phase III clinical trials following...
Bio-Thera Solutions Receives NMPA Approval for Combined Phase Ib/II Study of BAT7104 and BAT4706
Bio-Thera Solutions Ltd (SHA: 688177), a Chinese biopharmaceutical company, has announced that it has received...
Eisai’s Lemborexant Sleep Aid Lemborexant Filed for NMPA Approval in China
The China Center for Drug Evaluation (CDE) website has indicated that Japan-based Eisai (TYO: 4523)...
Joincare Pharmaceutical’s Partner Fermion Gets NMPA Green Light for Pain Drug Clinical Study
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has announced that...
GSK Secures Second Indication Approval for Nucala in China for Severe Eosinophilic Asthma
GSK plc (NYSE: GSK) has received approval for a second indication in China for its...
Eli Lilly Secures NMPA Approval for Emgality as Preventive Migraine Treatment in China
Eli Lilly (NYSE: LLY) has received marketing approval from the National Medical Products Administration (NMPA)...
GenFleet’s SLS009 Receives Fast-Track and Orphan Drug Designations from U.S. FDA for Lymphoma and Leukemia
Shanghai-based biotech GenFleet Therapeutics announced that its CDK9 inhibitor, SLS009 (GFH009), has received fast-track and...
Novartis’s Cosentyx Secures Additional Indication for Psoriatic Arthritis in China
Swiss pharmaceutical giant Novartis (SWX: NOVN) has announced that its drug Cosentyx (secukinumab), which targets...
Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
The US Food and Drug Administration (FDA) has accepted for priority review a filing from...