NMPA Unveils Measures to Support High-End Medical Device Innovation with Full Lifecycle Regulation
China’s National Medical Products Administration (NMPA) last week released the “Measures to Optimize Full-lifecycle Regulation...
AstraZeneca in Talks for $15B Licensing Deal for Ivonescimab with Summit Therapeutics
UK-based AstraZeneca plc (AZ, NASDAQ: AZN) is reportedly in negotiations with Summit Therapeutics, the US...
Jiangsu Vcare PharmaTech’s VC004 NDA Accepted for Review by China’s NMPA
China-based Jiangsu Vcare PharmaTech Co., Ltd announced that its New Drug Application (NDA) for VC004...
Novartis’ Cosentyx Fails to Meet Primary Endpoint in GCAptAIN Study for Giant Cell Arteritis
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced this week that its Phase III GCAptAIN study...
Eli Lilly’s Mounjaro Approved by China’s NMPA for Obstructive Sleep Apnea in Obese Adults
US pharma giant Eli Lilly & Co. (NYSE: LLY) announced that it has received a...
Akeso Biopharma Initiates Phase Ia Clinical Study for Trop2/Nectin4 Bispecific ADC AK146D1
China-based Akeso Biopharma (HKG: 9926) announced the initiation of a Phase Ia clinical study for...
Jiangsu Kanion Receives NMPA Approval for KYS2301 Gel in Atopic Dermatitis Clinical Study
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) announced that it has received approval from...
Sino Biopharmaceutical’s Recombinant Factor VIIa N01 Approved by NMPA for Hemophilia Treatment
China’s Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received marketing approval from the...
Thermo Fisher’s Oncomine Dx Express Test Approved by FDA as Companion Diagnostic for Dizal’s Zegfrovy
US-based Thermo Fisher Scientific Inc. (NYSE: TMO) announced that it has received marketing approval from...
Jiangsu Hengrui Announces NMPA Approval for Miebo in Dry Eye Disease Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received marketing approval...
China’s WeiMai Plans Hong Kong IPO to Expand AI-Powered Healthcare Services
China-based WeiMai Inc. plans to make an initial public offering (IPO) to the Hong Kong...
MSD’s Winrevair Accepted for Priority Review by FDA for Pulmonary Arterial Hypertension
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that the US Food...
Hangzhou Jiuyuan Announces NMPA Approval for Generic Doptelet in Thrombocytopenia Treatmen
Hangzhou Jiuyuan Gene Engineering Co., Ltd. (HKG: 2566) announced that it has received marketing approval...
Betta Pharmaceuticals’ Kangmeina Approved by NMPA for Advanced Breast Cancer Treatment
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received market approval from...
BioVersys Partners with Shionogi to Advance BV500 for Non-Tuberculous Mycobacterial Infections
Swiss biopharma BioVersys AG (SWX: BIOV) announced a research and exclusive license option agreement with...
Regeneron’s Lynozyfic Granted FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
US-based Regeneron Pharmaceuticals Inc., (NASDAQ: REGN) announced that it has received accelerated approval from the...
Sumitomo Pharma’s Xenleta Approved in China for Community-Acquired Pneumonia Treatment
Japan-based Sumitomo Pharma Co., Ltd announced that it has received market approval in China for...
BEBT-908 Receives Conditional NMPA Approval for Relapsed/Refractory DLBCL
Guangzhou BeBetter Medicine Technology Co., Ltd’s first-in-class HDAC/PI3Kα dual-targeted inhibitor BEBT-908 has received conditional approval...
Fosun Pharma Subsidiary Launches Co-Developed Biochemical Reagent with Siemens Healthineers
Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) subsidiary Fosun Diagnostics (Shanghai) Co.,...
CSPC Pharma Receives NMPA Approval for Hydroxocobalamine in Pediatric MMA Treatment
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received clinical trial approval...