CStone Pharmaceuticals Receives NMPA Approval for Local Production of Gavreto in China
China-based CStone Pharmaceuticals (HKG: 2616) has announced that it has received approval from the National...
Drug
Eli Lilly’s Kisunla (Donanemab) Receives FDA Label Update with New Dosing Schedule for Alzheimer’s Treatment
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has announced that the US Food...
Jiangsu Chia Tai Tianqing’s Culmerciclib Receives NMPA Review for Expanded Breast Cancer Indication
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...
Simcere and Connect Biopharma’s Rademikibart NDA Accepted by China’s NMPA for Atopic Dermatitis
The New Drug Application (NDA) for rademikibart, an anti-inflammatory monoclonal antibody (mAb) co-developed by China’s...
IASO Biotherapeutics Receives Orphan Drug Designation in South Korea for Fucaso in Multiple Myeloma
China-based IASO Biotherapeutics announced that its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso...
Guangdong Taienkang Submits Marketing Application for Generic Vuity to China’s NMPA
China-based Guangdong Taienkang Pharmaceutical Co., Ltd. (SHE: 301263) announced the submission of a marketing approval...
Innovent’s Dabote Becomes First China-Originated KRAS G12C Inhibitor Approved in Macau
China-based biopharma leader Innovent Biologics Inc. (HKG: 1801) has announced a significant regulatory milestone with...
Hengrui Pharmaceuticals Receives NMPA Clearance for SHR-2173 in Primary Membranous Nephropathy
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received clearance from...
J&J Submits sNDA to FDA for Caplyta to Prevent Schizophrenia Relapse
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced the submission of a supplemental New...
Novartis’ Coartem Baby Approved by Swissmedic for Newborns and Young Infants
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received marketing approval from Swissmedic...
Jiangsu Hengrui Gains NMPA Clinical Clearance for HRS-9821 in COPD Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received clinical clearance...
HutchMed Announces First Commercial Shipments of Tazverik Across China
China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the first commercial shipments of Tazverik (tazemetostat) across...
RemeGen Submits New Indication Application for Disitamab Vedotin in Urothelial Carcinoma
RemeGen Ltd (HKG: 9995) announced that the National Medical Products Administration (NMPA) in China has...
Grand Pharma’s SIR-Spheres Y-90 Gets FDA Accelerated Approval for Unresectable HCC
China-based Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR-Spheres Y-90 resin microspheres (SIR-Spheres), a...
Boehringer Ingelheim Starts Phase III THULITE Study for BI 1815368 in Diabetic Macular Edema
German pharmaceutical major Boehringer Ingelheim announced the initiation of the Phase III THULITE study to...
Roche’s Chugai Pharmaceutical Partners with Gero to Develop Therapies for Age-Related Diseases
Roche’s Japan-based subsidiary Chugai Pharmaceutical Co., Ltd. (TYO: 4519) announced this week a joint research...
Jiangsu CTTQ’s TQB2102 Receives Breakthrough Therapy Designation for HER2+ Breast Cancer
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...
Wepon Medical Receives NMPA Clinical Approval for WP107 in Generalized Myasthenia Gravis
Wepon Medical Holding Group Co., Ltd. (SHE: 002082) announced that it has received clinical approval...
SCG Cell Therapy Obtains NMPA Approval for SCG101V in Chronic HBV Study
China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has approved SCG...
AstraZeneca’s Imfinzi Approved in EU for Perioperative Treatment of Muscle-Invasive Bladder Cancer
UK-based AstraZeneca (AZ, NASDAQ: AZN) announced that it has received marketing approval in the European...