ImmuneOnco’s IMM2510 and IMM27M Achieve Milestones in Phase I Clinical Trials
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for...
Drug
CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy...
Sichuan Kelun Pharmaceutical Submits Biosimilar Cetuximab for NMPA Approval
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech...
United Laboratories’ UBT251 Receives Tacit Approval for NAFLD Clinical Study in China
Hong Kong firm United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category...
Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval...
AriBio Files for Phase III Clinical Trial Approval in China for Alzheimer’s Drug AR1001
South Korean clinical-stage biotech AriBio Co. has announced the filing for Phase III clinical trial...
Allist Pharmaceuticals and ArriVent Biopharma Release Promising Interim Data on Furmonertinib for NSCLC
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly...
BMS Announces Positive Outcomes for BMS-986278 in Progressive Pulmonary Fibrosis Study
Bristol-Myers Squibb (BMS; NYSE: BMY) has released the final results from a Phase II trial...
EMA Reviews Janssen’s Balversa for Advanced Urothelial Carcinoma with FGFR3 Alterations
The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen...
United Laboratories Receives Tacit Approval for JAK1 Inhibitor TUL01101 Clinical Trial
Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced tacit clinical trial approval...
Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval...
Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for...
Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease...
European Commission Approves Pediatric Indication for MSD’s Ervebo Ebola Vaccine
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) approval for...
Cutia Therapeutics’ CU-40102 Meets Primary Endpoint in Phase III Study for Androgenic Alopecia
Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its Phase III clinical study...
AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food...
Chengdu Kanghua Receives FDA Approval for Clinical Trial of Norovirus Vaccine
China-based Chengdu Kanghua Biological Products Co., Ltd (SHE: 300841) has announced that it has received...
Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed...
Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD)...
Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for...