Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its...
Drug
Takeda’s Livtencity Receives NMPA Approval, a First in China for CMV Infection Treatment
Japanese pharmaceutical company Takeda (TYO: 4502) has received its first market approval from China’s National...
AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III...
Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for...
FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns
The US Food and Drug Administration (FDA) has declined to approve a filing from Merck,...
Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that...
RemeGen’s Telitacicept Secures FDA Approval for Global Phase III Study in Primary Sjogren’s Syndrome
RemeGen (HKG: 9995), a China-based pharmaceutical company, has received approval from the US Food and...
RemeGen Ltd Receives FDA Clearance for MSLN-Targeting ADC RC88 in Gynecological Tumors
China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical clearance...
Konruns Pharmaceutical Gets NMPA Approval for KC1036 Clinical Study in Juventus sarcoma
Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has received approval from the National Medical Products...
Staidson Pharmaceutical’s BDB-001 Earns Breakthrough Therapy Designation in China for AAV Treatment
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that its...
3SBio Subsidiary Gets Green Light for SSGJ-608 Ankylosing Spondylitis Study
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has received...
Lynk Pharmaceuticals Initiates Phase III Clinical Trial for Rheumatoid Arthritis Drug in China
China-based Lynk Pharmaceuticals Co., Ltd has announced that the first patient has been dosed in...
European Commission Expands Keytruda Indications for Advanced Cancer Treatments
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications...
HuidaGene Secures Rare Pediatric Disease Designation for CRISPR Therapy HG302 Targeting DMD
HuidaGene Therapeutics, based in China, has announced that it has received Rare Pediatric Disease Designation...
HighField Biopharmaceutical Doses First Patient in HFK1 Clinical Trial Targeting Solid Tumors
Hangzhou-based HighField Biopharmaceutical, a leader in immuno-oncology focused on innovative lipid-based therapies, has announced the...
EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
InventisBio’s KRAS G12C Inhibitor D-1553 Advances Toward Priority Review in China
According to the China Center for Drug Evaluation (CDE), Shanghai-based InventisBio Co., Ltd. (SHA: 688382)...
Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy...
Sirnaomics Ltd Granted FDA Approval for Phase I RSV mRNA Vaccine Study
Sirnaomics Ltd (HKG: 2257) has received approval from the US Food and Drug Administration (FDA)...
Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from...