Duality’s DB‑1317 ADC Receives IND Approval for ADAM9‑Targeted Solid Tumor Therapy
Duality Biologics (HKG: 9606) announced that its ADAM9‑targeting ADC candidate DB‑1317 has received Investigational New...
Drug
Biogen’s High‑Dose SPINRAZA Wins EU Approval for 5q SMA After Japan Nod
Biogen Inc. (NASDAQ: BIIB) announced that the European Commission (EC) has granted marketing authorization for a...
Gan & Lee’s Insulin Glargine Wins Ethiopia Approval, Challenging Sanofi’s Dominance
Gan & Lee Pharmaceuticals (SHA: 603087) announced that its insulin glargine injection and pre‑filled insulin...
Zelgen’s ZGGS18 & ZG005 Cleared by NMPA for Advanced Solid Tumor Studies
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA)...
Signet Therapeutics Completes Preclinical Study for SIGX2649, Pan‑TEAD Inhibitor for Solid Tumors
Signet Therapeutics, incubated by Xtalpi Inc. (HKG: 2228), announced completion of preclinical studies for SIGX2649,...
Vitalgen’s VGN‑R08b Gene Therapy Earns FDA Orphan Drug Designation for Gaucher Disease
Shanghai Vitalgen BioPharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has...
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...
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)...