Grand Pharmaceutical Files TLX591-CDx PSMA Diagnostic for Prostate Cancer in China
Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68...
Drug
D3 Bio’s KRAS Programs Advance: FDA Clears Phase I G12D Inhibitor D3S‑003 and Phase II G12C‑ERK Combo
D3 Bio announced FDA clearance for two clinical programs: a Phase I first‑in‑human study for D3S‑003,...
Aidea’s ADC205 HIV Combo Gets NMPA Nod for Clinical Trials, Targeting $2.8B Market
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that China’s National Medical Products Administration (NMPA)...
Shionogi’s Fetroja Wins China NMPA Approval for Complicated UTIs, Targets Resistant Gram‑Negative Infections
Shionogi Co., Ltd announced that China’s National Medical Products Administration (NMPA) has granted marketing approval...
Chiesi’s Raxone Begins LHON Treatment in China, First World‑Approved Therapy
Chiesi Group announced that the first patients have initiated treatment with Raxone (idebenone 150 mg) at...
Novartis’s Ianalumab Wins FDA Breakthrough Therapy Designation for Sjögren’s Disease
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...
Akeso’s Gumokimab NMPA Filing for Ankylosing Spondylitis Expands IL‑17A Franchise
Akeso Biopharma (HKG: 9926) announced that the Center for Drug Evaluation (CDE) of NMPA has...
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...
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)...