Qyuns Therapeutics and Huadong Medicine Secure NMPA Approval for Stelara Biosimilar HDM3001-2/QX001S in Crohn’s Disease
Qyuns Therapeutics (HKG: 2509) announced that HDM3001-2/QX001S, a biosimilar to Johnson & Johnson’s autoimmune therapy...
Drug
3D Medicines Enrolls First Patient in Pivotal Phase III Trial of Envafolimab for Resectable NSCLC
3D Medicines (HKG: 1244) announced the enrollment of the first patient in a Phase III...
Allergan Aesthetics Secures CHMP Positive Opinion for Boey (TrenibotulinumtoxinE) in Glabellar Lines Treatment Across European Economic Area
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that the European Medicines Agency’s (EMA) Committee...
Lupeng Pharma Enrolls First Patient in Global Phase 3 ROCKET-CLL Trial of Fourth-Gen BTK Inhibitor Rocbrutinib vs. Pirtobrutinib
Lupeng Pharmaceutical Ltd. announced the enrollment of the first patient in its global Phase 3...
Eli Lilly’s Retatrutide Delivers Breakthrough Weight Loss Results in Phase 3 TRIUMPH-1 Trial for Obesity Treatment
Eli Lilly and Company (NYSE: LLY) announced positive topline results from the TRIUMPH-1 Phase 3...
Merck KGaA Launches Phase III PROCEADE-CRC-03 Trial for First-in-Class CEACAM5 ADC Precemtabart Tocentecan in Metastatic Colorectal Cancer
Merck KGaA (ETR: MRK) announced the initiation of the Phase III PROCEADE-CRC-03 study, evaluating the...
Astellas and MSD’s PADCEV-Keytruda Combination Receives Positive CHMP Opinion for Muscle-Invasive Bladder Cancer in EU
Astellas Pharma Inc. (TYO: 4503) announced that the Committee for Medicinal Products for Human Use...
Hansoh Pharma’s HS-10504 Receives NMPA Breakthrough Therapy Designation for Fourth-Generation EGFR Inhibitor in Resistant NSCLC
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s Center for Drug Evaluation (CDE)...
Bayer’s Kerendia Receives FDA Priority Review for Expanded Indication in Type 1 Diabetes-Associated Chronic Kidney Disease
Bayer AG (ETR: BAYN) announced that the U.S. Food and Drug Administration (FDA) has accepted...
Yangtze River Pharma Secures NMPA Approval for Fazamorexant – Next-Generation DORA for Insomnia Treatment
Yangtze River Pharmaceutical Group (YRPG) announced that China’s National Medical Products Administration (NMPA) has granted...
Boehringer Ingelheim and Sino Biopharmaceutical Secure NMPA Conditional Approval for Hernexeos in First-Line HER2-Mutant NSCLC With 76% Response Rate
Boehringer Ingelheim (BI) and Sino Biopharmaceutical Ltd (HKG: 1177) jointly announced that Hernexeos (zongertinib) has...
Transcenta and Inhibrx Report 20% Response Rate for Ozekibart in Heavily Pretreated Colorectal Cancer, Following Recent FDA Filing for Chondrosarcoma
Transcenta Holdings Ltd (HKG: 6628) and its U.S. partner Inhibrx Biosciences, Inc. (NASDAQ: INBX) announced...
Mabwell Bioscience Secures Second NMPA Approval for Denosu Biosimilar, Expanding Indication to Bone Metastases and Multiple Myeloma
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received a second indication approval...
Pfizer’s 25-Valent Pneumococcal Vaccine Candidate Shows Superior Serotype 3 Response in Phase II Infant Study
Pfizer Inc. (NYSE: PFE) announced positive readouts from a Phase II clinical study evaluating its...
Sanofi’s Efdoralprin Alfa Demonstrates Superior fAAT Normalization in Alpha-1 Antitrypsin Deficiency Phase II ElevAATe Study
Sanofi SA (NASDAQ: SNY) announced today positive data from the global ElevAATe Phase II clinical...
Novartis’ Pluvicto Demonstrates Significant PSA Response Improvement in PSMA-Positive mHSPC Patients in PSMAddition Study
Novartis AG (NYSE: NVS) announced today new data from the PSMAddition Phase III clinical trial...
Bayer’s Asundexian Receives FDA Priority Review for Secondary Stroke Prevention Following Positive Phase III OCEANIC-STROKE Trial
Bayer AG (ETR: BAYN) announced today that the U.S. Food and Drug Administration (FDA) has...
United Laboratories Secures NMPA Tacit Approval for TUL108 Clinical Study in China Following US Trial Authorization
United Laboratories International Holdings Ltd (HKG: 3933) announced today it has received tacit approval from...
ImmuneOnco Doses First Patient in Phase II Trial of IMM0306 for Systemic Lupus Erythematosus
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced today the dosing of the first patient...
Bio-Thera Solutions Secures FDA Approval for Golimumab Biosimilars Immgolis and Immgolis Intri
Bio-Thera Solutions (SHA: 688177) announced it has received marketing approval from the U.S. Food and...