Datroway TNBC sBLA Gets FDA Priority Review for Triple-Negative Breast Cancer
AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug Administration...
Drug
Bayer Nubeqa Gets NMPA Approval for Metastatic Prostate Cancer
Bayer AG (ETR: BAYN) announced that the National Medical Products Administration (NMPA) has approved Nubeqa (darolutamide)...
Venglustat Gaucher: Sanofi Meets Primary Endpoint in Phase 3 LEAP2MONO Study
Sanofi (NASDAQ: SNY) announced positive results from the LEAP2MONO phase 3 study (NCT05222906), showing venglustat met the...
Eli Lilly Mounjaro Fails to Win EU Approval for HFpEF Heart Failure Indication
Eli Lilly (NYSE: LLY) announced that the European Medicines Agency (EMA) drug advisory panel declined to...
Imfinzi Gastric Cancer: AstraZeneca Secures CHMP Recommendation
AstraZeneca (AZ, NASDAQ: AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) has...
Chiesi’s Juxtapid Wins NMPA Approval for Rare Cholesterol Disorder in China
Chiesi Group’s China unit announced that the National Medical Products Administration (NMPA) has granted marketing...
Novartis Cosentyx Wins NMPA Approval for Non-Radiographic Axial Spondyloarthritis
Novartis (NYSE: NVS) announced that the National Medical Products Administration (NMPA) has approved Cosentyx (secukinumab) for...
Sciwind’s Ecnoglutide Wins NMPA Nod as First cAMP‑Biased GLP‑1 Agonist
Sciwind Biosciences Co., Ltd. announced that the National Medical Products Administration (NMPA) has approved ecnoglutide...
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...
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...
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...
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)...
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...