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...
Drug
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...
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)...
United Labs TUL108 Gets FDA Nod for Antibiotic Resistance Trial
United Laboratories International Holdings Ltd (HKG: 3933) announced that the U.S. Food and Drug Administration (FDA)...
MicuRx MRX-5 Gets FDA Nod for Phase II NTM Lung Disease Study
MicuRx Pharmaceuticals Inc., (SHA: 688373) a Sino‑US biopharmaceutical company, announced it has received approval from...
Huiyu Pharma HYP-6589 Gets NMPA Nod for NSCLC Osimertinib Combo
Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced that the National Medical Products Administration (NMPA)...
Changchun High‑Tech’s Firsekibart Filing Accepted for Non‑Infectious Uveitis
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that the National Medical Products...
Sino Biopharm’s TQA3605 Meets Endpoint in Hepatitis B Phase II Trial
Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Category 1 drug TQA3605 has met the primary...
J&J Darzalex Faspro Gets FDA Nod for NDMM D-VRd Regimen
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved...
Roche CT-388 Obesity Drug Shows 22.5% Weight Loss in Phase II Trial
Roche (SWX: ROG, OTCMKTS: RHHBY) announced positive topline results from its Phase II clinical trial (CT388‑103)...
Leqvio Gets NMPA Nod for Monotherapy in China Hypercholesterolemia
Novartis (NYSE: NVS) announced that Leqvio (inclisiran) has received an additional indication approval from the National...
Henlius Triple Combo Gets NMPA Nod for Advanced Solid Tumor Trials
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received National Medical Products Administration (NMPA)...
Hengrui’s HRS-5346 Lp(a) Inhibitor Gets China Breakthrough Therapy Designation in $1.97B Merck Deal
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS-5346, the centerpiece of a USD 1.97 billion...