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...
Drug
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...
Sanofi’s Amlitelimab Shows Promising Phase IIb Results in Atopic Dermatitis, Potential for 12-Week Dosing
Sanofi (NASDAQ: SNY) announced this week promising results from a Phase IIb study of its...
J&J’s Tremfya Files for Ulcerative Colitis Indication with FDA, Building on Positive Late-Stage Data
The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson...
Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food...
Everest Medicines’ Velsipity NDA Accepted in Macau, Poised for First Asian Approval
Everest Medicines (HKG: 1952), based in China, has announced that its New Drug Application (NDA)...
Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed...
ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched...
BeiGene Launches Legal Action Against Sandoz and MSN Over Brukinsa Patent Infringement
BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has initiated patent...
Eli Lilly Delays Donanemab Action Date as FDA Calls for Advisory Committee Review
Eli Lilly (NYSE: LLY) has announced a delay in the action date for its Alzheimer’s...
FDA Approves Wegovy for Cardiovascular Risk Reduction in Obese Patients, First of Its Kind
The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to...
Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4...
BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY)...