iRegene’s Pioneering Cell Therapy NouvNeu001 Administered in Wuhan for Parkinson’s Disease
Wuhan-based cell therapy developer iRegene has reached a clinical milestone with the administration of its...
Drug
Chengdu Kanghong Pharmaceutical Gets US FDA Nod for Clinical Trial of KH658 for Wet AMD
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a leading pharmaceutical company based in China,...
CARsgen Therapeutics Submits CAPA Report to US FDA Following Clinical Hold
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies...
Yantai Dongcheng Pharmaceutical Receives NMPA Approval for Advanced Solid Tumor Therapy
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China,...
Keymed Biosciences’ Stapokibart Meets Primary Endpoint in Phase III Seasonal Allergic Rhinitis Study
China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that its IL-4Rα monoclonal antibody...
Pfizer’s Gene Therapy Beqvez Wins FDA Nod for Moderate-to-Severe Hemophilia B
The US Food and Drug Administration (FDA) has granted marketing authorization to Pfizer (NYSE: PFE)...
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...
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,...