MSD’s Once-Daily HIV-1 Therapy Doravirine/Islatravir NDA Accepted by FDA for Review
Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration...
Drug
Zelgen’s ZG006 Receives Breakthrough Therapy Designation for Advanced Small Cell Lung Cancer
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received breakthrough therapy...
Cosunter’s GST-HG131 Granted Breakthrough Therapy Designation for HBV Treatment in China
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) announced that it has received breakthrough therapy...
Ascentage Pharma’s Lisaftoclax Receives NMPA Approval for CLL/SLL Treatment
China-based Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) announced that it has received conditional marketing approval...
Allist’s Furmonertinib Granted Priority Review for EGFR Exon 20 NSCLC in China
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that its Category 1 small molecule...
HKYM Biopharma’s KM1 Receives NMPA Green-Light for Phase Ib/II Study in Advanced Solid Tumors
Shenzhen-based oncolytic virus specialist HKYM Biopharma has announced receiving the green-light from the National Medical...
United Laboratories Receives FDA Approval for Clinical Study of UBT37034 in Overweight/Obesity Treatment
Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced that it has received...
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...
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...