KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA)...
Drug
Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has...
Madrigal Pharmaceuticals’ Rezdiffra Earns FDA Accelerated Approval for NASH in Adults
The US Food and Drug Administration (FDA) has granted an accelerated approval to Madrigal Pharmaceuticals’...
CNIPA Invalidates AbbVie Patents, Setting New Precedent for Pharmaceutical Disclosure
The China National Intellectual Property Administration (CNIPA)’s Patent Re-examination Board (PRB) has reportedly invalidated two...
European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent...
Merck Plans Broader HPV Vaccine Development, Targeting African and Asian Populations
Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled plans to develop a multi-valent human...
Allist Pharmaceuticals Secures NMPA Approval for Phase I Study of AST2169 Liposome in KRAS G12D Tumors
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) has received clearance from the National Medical...
Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has received approval from the National Medical Products...
Genor Biopharma Secures NMPA Review for Lerociclib in Advanced Breast Cancer Indication
Genor Biopharma Co., Ltd. (HKG: 6998) has announced that the National Medical Products Administration (NMPA)...
Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug...
Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National...
Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market...
CORXEL Gets CDE Green Light for Phase III Aficamten Study in nHCM
CORXEL, formerly known as Ji Xing Pharmaceuticals, a China-based pharmaceutical company, has announced that it...
InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has...
Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it...
Fosun Pharmaceutical Gets NMPA Green Light for Phase I Study of Fibrosis Drug HLX6018
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based...
Kelun-Biotech’s A400 Receives Fast-Track Status from FDA for RET Fusion-Positive NSCLC
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan...
Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance...
Huadong Medicine Secures NMPA Approval for HDM1005, Targeting Type 2 Diabetes and Obesity
Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that it has received...
Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics...