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...
Drug
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)...
BeiGene’s Brukinsa Receives FDA Approval for Relapsed or Refractory Follicular Lymphoma
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biotech company based in China,...
Visen Pharmaceuticals’ TransCon hGH Accepted for Review by China’s NMPA
Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma and Chinese healthcare-focused investment firm Vivo...
Shanghai Fosun Pharma Gets NMPA Green Light for Universal NK Cell Therapy GCK-01 Clinical Study
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based...
Novo Nordisk’s Anti-Obesity Drug Wegovy Eyed for China Launch in 2024
Novo Nordisk (NYSE: NVO), a leading diabetes company based in Denmark, has reportedly informed investors...
China Grand Pharmaceutical Receives FDA Approval for Post-Surgical Ophthalmic Drug GPN00833
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has...
Shanghai Fosun Pharma Gets NMPA Green Light for XS-02 Solid Tumor Clinical Study
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based...
Boehringer Ingelheim’s Spevigo Receives NMPA Approval for GPP Treatment in China
German pharmaceutical giant Boehringer Ingelheim (BI) has announced that it has received marketing approval from...
Luye Pharma Launches Small-Cell Lung Cancer Treatment Zepzelca in Hong Kong and Macau
Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the official market launch...
CARsgen Launches BCMA-Targeted CAR-T Therapy in China with High Price Point
China-based CAR-T cell therapy specialist CARsgen Therapeutics Holdings Ltd. (HKG: 2171) has launched its BCMA-targeted...
Xian Janssen’s Tremfya Heads for Priority Review in China for Crohn’s Disease Treatment
The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an...
EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson...