Huadong Medicine’s DR10624 Wins FDA Nod for MASLD Study, First Triple Agonist to Enter Clinic
Huadong Medicine Co., Ltd (SHE: 000963) announced that the U.S. Food and Drug Administration (FDA) has...
Drug
Ipsen’s IPN60340 Wins FDA Breakthrough Therapy Designation for First‑Line AML in Combination
Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has granted...
BMS’s Mavacamten Shows Significant LVOT Reduction in First Adolescent oHCM Phase III Study
Bristol‑Myers Squibb (BMS, NYSE: BMY) announced positive topline results from the Phase 3 SCOUT‑HCM study evaluating mavacamten...
J&J’s TECVAYLI Shows 71% PFS Reduction in Phase 3 MajesTEC‑9 for Multiple Myeloma
Johnson & Johnson (J&J, NYSE: JNJ) announced positive topline results from the Phase 3 MajesTEC‑9 study of...
Leads Biolabs’ Opamtistomig Secures FDA Fast Track for EP-NEC as First 4-1BB Bispecific
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that the U.S. Food and Drug Administration (FDA)...
ImmuneOnco’s IMM2510 Advances to Phase II/III in Endometrial Cancer After Axion Bio Deal Termination
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has...
Henlius’s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Haichang Biotech’s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma
Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...
Sanofi’s Teizeild Wins EU Approval as First Disease‑Modifying Therapy for Type 1 Diabetes
Sanofi (NASDAQ: SNY) announced that the European Commission has approved Teizeild (teplizumab), a CD3‑targeted monoclonal antibody,...
CSPC’s Prusogliptin/Metformin FDC NDA Accepted by NMPA for Type 2 Diabetes, Targeting 60 M Underserved Patients
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted...
ImmuneOnco’s Timdarpacept Receives NMPA Nod for Atherosclerosis Study, Expanding CD47 Platform
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has...
Hengrui’s SHR‑1826 ADC Earns Breakthrough Therapy Designation for c‑Met Overexpressed NSCLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that SHR‑1826, an antibody‑drug conjugate (ADC) targeting...
Hengrui’s HRS-7535 GLP-1R Agonist Cleared for Hypertension with Obesity Study in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA)...
Merck and Abbisko’s Pimicotinib NDA Accepted by FDA for TGCT, Building on China Approval
Merck KGaA (ETR: MRK) and Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the U.S. FDA...
FDA Approves Zycubo as First Therapy for Pediatric Menkes Disease, Targeting Ultra‑Rare Copper Deficiency Disorder
The U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection, the first...
BMS’s Camzyos Meets Primary Endpoint in Phase III SCOUT-HCM Study for Adolescent oHCM
Bristol-Myers Squibb (NYSE: BMY) announced that the SCOUT‑HCM Phase III study of Camzyos (mavacamten) met its primary...
Summit Therapeutics Submits Ivonescimab BLA to FDA for EGFR‑Mutated NSCLC Post Third‑Gen TKI
Summit Therapeutics (NASDAQ: SMMT), the US partner of Akeso Inc. (HKG: 9926), announced the submission of...
Alphamab Oncology Submits Envafolimab for First‑Line Biliary Tract Cancer (BTC) as World’s First Subcutaneous PD‑L1
Alphamab Oncology (HKG: 9966) announced that China’s National Medical Products Administration (NMPA) has accepted its marketing...
Pfizer’s BRAFTOVI Trio Achieves 64 % Response Rate in BREAKWATER Cohort 3 for BRAF V600E Metastatic Colorectal Cancer
Pfizer Inc. (NYSE: PFE) announced that Cohort 3 of the pivotal Phase 3 BREAKWATER trial met its primary...