FDA Opens PreCheck Applications to Strengthen Domestic Drug Manufacturing
The U.S. Food and Drug Administration this week began accepting applications for the FDA PreCheck...
Ab&b Bio-Tech’s Trivalent Influenza Vaccine Wins NMPA Nod for All Ages
Ab&b Bio-Tech Co.,Ltd. (HKG: 2627) announced that the National Medical Products Administration (NMPA) has granted...
Sanofi Rezurock Wins EU Backing for Graft‑Versus‑Host Disease
Sanofi (NASDAQ: SNY) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human...
CMS-D017 Gets NMPA Nod for PNH Clinical Trial
China Medical System Holdings (CMS; HKG: 0867) announced that the National Medical Products Administration (NMPA) has...
J&J AKEEGA Gets CHMP Nod for BRCA-Mutated Prostate Cancer
Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products for Human Use...
Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
CDE Seeks Feedback on 103rd Batch of Generic Reference Preparations
The Center for Drug Evaluation (CDE) is seeking industry feedback on the 103rd batch of...
Kyowa Kirin Reclaims Rocatinlimab Rights from Amgen in Strategic Shift
Kyowa Kirin (TYO: 4151) announced it will cancel its licensing agreement with Amgen (NASDAQ: AMGN) for...
Chiesi Fabry Drug Pegunigalsidase Alfa Wins CHMP Backing for Extended Dosing
Chiesi Group announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended...
Novo Nordisk Appoints Yan Cai as Greater China President Amid LeadershipChange
Novo Nordisk (NYSE: NVO) announced that Zhou Xiaping, Senior Vice President and President of Greater China,...
China Medical’s Opzelura Cream Gets NMPA Approval for Vitiligo
China Medical System Holdings (CMS; HKG: 0867) announced that the National Medical Products Administration (NMPA) has...
Zhaoke Ophthalmology’s Yuvezzi Gets FDA Nod for Presbyopia
Zhaoke Ophthalmology (HKG: 6622) announced that its UK partner Tenpoint Therapeutics has received FDA clearance...
CSPC’s SYS 6055 CAR-T Gets NMPA Nod for Lymphoma Trials
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the National Medical Products Administration (NMPA) has approved...
AstraZeneca Commits $14.4B China Investment in Cell Therapy Push
AstraZeneca (AZ, NASDAQ: AZN) announced a plan to invest RMB 100 billion (USD 14.4 billion) :in China by 2030 to...
Ascletis ASC40 Phase III Success in Acne Vulgaris
Ascletis Pharma Inc (HKG: 1672) announced positive top‑line results from the open‑label Phase III study (NCT06248008)...
Thermo Fisher Reports Q4 Revenue Growth on AI Innovation
Thermo Fisher Scientific Inc. (NYSE: TMO) reported fourth‑quarter revenue of $12.21 billion , up 7% year‑on‑year (YOY),...
TYK Medicines Asandeutertinib Gets China Priority Review for NSCLC Brain Metastases
TYK Medicines, Inc. (HKG: 2410) announced that its Category 1 drug asandeutertinib (TY‑9591), a third‑generation EGFR...
Takeda Q3 Revenue Drops 3.3% on VYVANSE Generics, Raises Full-Year Forecast
Takeda Pharmaceutical Co. (TYO: 4502, NYSE: TAK) reported third‑quarter fiscal 2025 revenue of 3,411.2 billion yen (USD 22.17 billion), down...
Tyligand Bio Files Hong Kong IPO with Phase II KRAS G12D Inhibitor TSN1611
Tyligand Bioscience Ltd. this week submitted its initial public offering (IPO) filing to the Hong...
Hengrui Cancer Combo Gets NMPA Nod for Liver Cancer Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that a supplementary Biologics License Application (sBLA)...