Viatris Submits Fast-Acting Meloxicam NDA to FDA for Moderate-to-Severe Acute Pain; Decision Expected December 2026
Viatris Inc. (NASDAQ: VTRS) announced that the U.S. Food and Drug Administration (FDA) has accepted...
Drug
Regeneron’s Fianlimab-Cemiplimab Combination Fails to Meet Primary Endpoint in Phase III Melanoma Trial – LAG-3/PD-1 Dual Therapy Shows No PFS Benefit Over Pembrolizumab Monotherapy
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that its Phase III clinical trial evaluating fianlimab (LAG-3...
AstraZeneca’s Baxfendy Secures FDA Approval for Uncontrolled Hypertension – First-in-Class Aldosterone Synthase Inhibitor with Selective CYP11B2 Targeting
AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has granted marketing...
Harbour BioMed Unveils Preclinical Data for LET003 – AI-Discovered ACVR2A/2B Antibody Shows Best-in-Class Potential in Obesity Combination Therapy with GLP-1 Drugs
Harbour BioMed (HKG: 2142) has published preclinical data for LET003, an ACVR2A/2B-targeted monoclonal antibody (mAb)...
AstraZeneca and Daiichi Sankyo’s ENHERTU Secures Dual FDA Approval for HER2-Positive Early Breast Cancer – Neoadjuvant and Adjuvant Indications Supported by Landmark Phase 3 Data
AstraZeneca (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug...
Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...
Biogen’s Zorevunersen Receives China Breakthrough Therapy Designation for Dravet Syndrome – First ASO Targeting SCN1A Gene in Rare Epileptic Encephalopathy
Biogen Inc. (NASDAQ: BIIB) announced that zorevunersen, an investigational antisense oligonucleotide (ASO) for Dravet syndrome,...
Shanghai CureGene’s CG-0255 Receives NMPA Clearance for Ischemic Stroke Clinical Trial – First Thiol-Based P2Y12 Inhibitor Overcoming Clopidogrel Resistance
Shanghai CureGene Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...
Shenzhen Salubris Secures Chinese Approval for Xinfutai Plus – First Once-Weekly Teriparatide for High-Risk Postmenopausal Osteoporosis
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced market approval from China’s National Medical Products...
Changchun GeneScience’s GenSci161 Receives FDA Clearance for Hidradenitis Suppurativa Clinical Trial – Novel Bispecific Antibody Targeting IL-1α/IL-1β
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun...
Amgen’s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration
Amgen Inc. (NASDAQ: AMGN) announced that China’s National Medical Products Administration (NMPA) has accepted for...
Chongqing Genrix Bio Receives NMPA Clinical Approval for GR1803 Bispecific Antibody in Relapsed/Refractory Multiple Myeloma
Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced it has received clinical trial approval...
AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer
AstraZeneca plc (NYSE: AZN) released high-level results from a prespecified interim analysis of the Phase...
Chipscreen Biosciences Secures Macao Market Approval for Bilessglu (Chiglitazar), Novel PPAR Pan-Agonist for Type 2 Diabetes
Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced it has received marketing clearance from the Pharmaceutical...
Biogen Reports Positive Phase II CELIA Results for Diranersen, First-in-Class Tau-Targeting ASO Therapy in Early Alzheimer’s Disease
Biogen Inc. (NASDAQ: BIIB) announced positive top-line results from the Phase II CELIA study, evaluating...
Hengrui Pharmaceuticals Secures NMPA Clinical Approval for RSS0393 Latex in Atopic Dermatitis Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical approval...
Sichuan Biokin Receives NMPA Go-Ahead for SI-B036 Bispecific Antibody Clinical Study in Advanced Solid Tumors
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...
Hansoh Pharma Receives NMPA Approval for HS-10541 Phase I Trial – Category 1 KRAS G12C Inhibitor Targets Advanced Solid Tumors
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced it has received regulatory approval from China’s...
Pfizer’s Hympavzi Gains European Approval for Hemophilia with Inhibitors – Novel TFPI-Targeting Therapy Offers Weekly Subcutaneous Alternative to Factor Replacement
Pfizer Inc. (NYSE: PFE) announced it has received European Commission (EC) approval for an indication...
Henlius Biotech Secures Australian TGA Approval for HLX48 Phase I Trial – Novel EGFR/c-Met Bispecific ADC Targets Advanced Solid Tumors
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received regulatory approval from Australia’s Therapeutic...