Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for...
Drug
HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502,...
Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan...
AbbVie’s Rinvoq Outperforms Sanofi’s Dupixent in Moderate-to-Severe Atopic Dermatitis Trial
AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing...
Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies...
Chia Tai Tianqing’s TQA3038 siRNA Drug Completes Phase I Clinical Trial for Chronic Hepatitis B
Chia Tai Tianqing has announced the successful completion of a Phase I clinical study for...
US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food...
Novartis Receives Positive Interim Results for Antimalarial Coartem in Infants
Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical...
Hebei Changshan Biochemical’s Albenatide File for Type 2 Diabetes Accepted by China’s NMPA
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced that the National Medical...
Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III...
Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS)...
Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong...
Abbisko Therapeutics’ Irpagratinib Earns Orphan Drug Designation from US FDA for Hepatocellular Carcinoma
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received Orphan Drug Designation (ODD)...
Sanofi’s Rilzabrutinib Meets Primary Endpoint in Phase III ITP Trial
French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its Phase III trial for rilzabrutinib,...
European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam +...
BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has...
Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced the...
China Medical System Holdings’ Desidustat NDA Accepted for Review by China’s NMPA
China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration...
Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application...
Huadong Medicine’s HDM1005 Receives US FDA Clinical Trial Approval for Weight Management
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial...