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...
Drug
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...
Lundbeck’s Asedebart Receives Japanese Orphan Drug Designation for Congenital Adrenal Hyperplasia and Cushing’s Disease
Lundbeck (OTCMKTS: HLUBF) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted...
Leads Biolabs’ Opamtistomig Becomes World’s First 4-1BB Bispecific Antibody to Enter Pivotal Phase III for EP-NEC
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced it has received regulatory clearance in China...
CSPC Pharmaceutical Receives NMPA Clinical Trial Approval for SYH2095, World’s First KAT6 Inhibitor
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received clinical trial approval from China’s...
Boehringer Ingelheim’s JASCAYD (Nerandomilast) Approved in Japan for IPF and Progressive Pulmonary Fibrosis
Boehringer Ingelheim (BI) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted...
Bayer’s HYRNUO Receives FDA Priority Review for First-Line HER2-Mutated NSCLC Treatment
Bayer AG (ETR: BAYN) announced that the U.S. Food and Drug Administration (FDA) has granted...
Sanegene Bio’s C3-Targeted siRNA SGB-9768 Expands to Hematological Disorders Following NMPA Clinical Trial Approval
Suzhou Sanegene Bio Inc., an RNAi specialist with R&D centers in the U.S. and China,...
Hengrui’s HER3-Targeting ADC SHR-A2009 Achieves Phase III Success in EGFR-Mutated NSCLC After TKI Failure
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the Phase III SHR-A2009-301...
Merck’s Sacituzumab Tirumotecan Demonstrates First-Ever OS and PFS Benefit in Phase 3 Endometrial Cancer Trial
Merck & Co., Inc. (MSD) (NYSE: MRK) announced that the pivotal Phase 3 TroFuse-005 trial...