EMA CHMP Recommends Revocation of TAVNEOS Marketing Authorization Following Data Integrity Concerns in ADVOCATE Trial
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL Limited announced that the European Medicines...
Drug
Abbisko Therapeutics Secures FDA IND Clearance for Pan-KRAS Inhibitor ABSK211, Targeting Broad Spectrum of KRAS Alterations in Solid Tumors
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the U.S. Food and Drug Administration (FDA)...
LongBio Pharma Secures FDA IND Approval for Novel Anti-IgE Antibody LP-003 in Peanut Allergy, Expanding Global Allergic Disease Pipeline
LongBio Pharma (Suzhou) Co., Ltd. (HKG: 1779) announced that the clinical trial application for LP-003...
Pfizer and Astellas Secure FDA Approval for PADCEV-KEYTRUDA Combination as First Platinum-Free Neoadjuvant/Adjuvant Therapy for Muscle-Invasive Bladder Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced that the U.S. Food...
Sanofi Secures FDA Approval for Sarclisa Escena Subcutaneous Formulation, First Dual-Administration Anti-Cancer Therapy for Multiple Myeloma
Sanofi S.A. (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has approved...
Hansoh Pharma’s B7-H3 ADC Risvutatug Rezetecan Meets Primary Endpoint in Phase III SCLC Trial, Showing Significant Survival Benefit Over Topotecan
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that Risvutatug Rezetecan (HS-20093), its proprietary B7-H3-targeted...
TransThera Secures NMPA Approval for Phase 2 Trial of TT-00973 in Combination with Firmonertinib for EGFR-Mutant NSCLC
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) has...
Salubris Pharmaceuticals Secures NMPA IND Clearance for SAL0167 – Proprietary Cyclic Peptide Targeting Hyperlipidemia
Shenzhen Salubris Pharmaceuticals (SHE: 002294) announced that China’s National Medical Products Administration (NMPA) has cleared...
Jacobio Pharma’s Incubator Secures NMPA IND Clearance for JAR-2203 Injection – Novel Therapy Targeting Hyperlipoproteinemia(a)
Jacobio Pharmaceuticals (HKG: 1167) announced that its portfolio company, Jacobio-Raikang, has received National Medical Products...
Haixi Pharma Launches Phase III Trial of C019199 – First-in-Class Multi-Targeted Immunomodulator for Refractory Osteosarcoma
Haixi Pharmaceutical announced it has officially initiated its Phase III clinical trial (CTR20261818) evaluating C019199,...
Astellas Pharma Submits BLA to China NMPA for PADCEV-Keytruda Combination in Muscle-Invasive Bladder Cancer, Showing 60% Reduction in Recurrence Risk for Cisplatin-Ineligible Patients
Astellas Pharma Inc. (TYO: 4503) announced that China’s National Medical Products Administration (NMPA) has accepted...
Jiangsu Aidea Pharmaceutical Receives NMPA Clinical Trial Approval for ADC119, China’s First Domestic Complete HIV Regimen Combining Novel NNRTI with Established NRTIs
Jiangsu Aidea Pharmaceutical Co., Ltd. (SHA: 688488) announced that China’s National Medical Products Administration (NMPA)...
Shenyang Xingqi Pharmaceutical Reports Positive Phase 2 Results for SQ-22031 Eye Drops in Neurotrophic Keratitis, Advances to Pivotal Phase 3 Trial
Shenyang Xingqi Pharmaceutical Co., Ltd. (SHE: 300573) announced positive results from its Phase 2 clinical...
Changchun High & New Technology’s Subsidiary GenSci Secures NMPA IND Acceptance for GenSci148, First-in-Class VEGF Multi-Blocker for Retinal Vascular Diseases
Changchun High & New Technology Industry (Group) Inc. (SHE: 000661) announced that China’s National Medical...
AbbVie Secures European Commission Approval for TEPKINLY Combination Therapy in Relapsed/Refractory Follicular Lymphoma with 79% Reduction in Disease Progression Risk
AbbVie Inc. (NYSE: ABBV) announced that the European Commission (EC) has granted marketing authorization for...
Mabwell Bioscience Secures NMPA Approval for 9MW5211 Antibody in Type 1 Diabetes, Expanding Autoimmune Pipeline
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062, HKG: 2493) announced that its clinical trial application...
Hengrui Pharmaceuticals Secures NMPA Clinical Approval for First-in-Class SHR-4685 in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its proprietary SHR-4685 has...
Qihan Biotech Secures NMPA Approval for Dual-Target Allogeneic CAR-T Therapy QT-019C in Refractory Lupus
Hangzhou Qihan Biotech Engineering Life (“Qihan Biotech”) announced that its QT-019C cell injection has received...
Insilico Medicine Launches Phase 3 Trial for AI-Discovered Rentosertib in Idiopathic Pulmonary Fibrosis
Insilico Medicine (HKG: 3696) announced the initiation of a Phase 3 clinical trial (CTR20262475, NCT07687459)...
LTZ Therapeutics Secures FDA IND Approval for LTZ-232, First-in-Class Myeloid Engager Targeting EpCAM-High Solid Tumors
LTZ Therapeutics announced that its second drug candidate, LTZ-232, has received Investigational New Drug (IND)...