Bio-Thera’s Gotenfia Wins European Approval as Simponi Biosimilar
Bio-Thera Solutions Inc. (SHA: 688177) announced that the European Commission (EC) has approved Gotenfia (BAT2506), its...
Drug
Amgen’s UPLIZNA Wins European Approval for Generalized Myasthenia Gravis
Amgen Inc. (NASDAQ: AMGN) announced that the European Commission (EC) has approved UPLIZNA (inebilizumab) as an...
Innovent Biologics Initiates Phase 3 HeriCare-Breast01 Study for IBI354 in HER2+ Breast Cancer
Innovent Biologics, Inc. (HKG: 1801) announced first patient dosing in the pivotal Phase 3 HeriCare-Breast01 study...
MSD’s Keytruda Wins FDA Approval for Platinum-Resistant Ovarian Cancer
Merck & Co. (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has...
Henlius Biotech Initiates Phase Ib/II Study for HLX43 ADC Combinations in Colorectal Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced first patient dosing in a Phase Ib/II clinical study...
Eli Lilly’s Jaypirca Wins NMPA Approval for CLL/SLL Post-BTK Inhibitor Therapy
Eli Lilly and Company (NYSE: LLY) announced that the National Medical Products Administration (NMPA) has approved...
Hengrui’s Trastuzumab Rezetecan Wins Eighth BTD for First-Line HER2+ NSCLC in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that trastuzumab rezetecan (SHR-A1811), its HER2-targeted antibody-drug...
SciClone’s Tasurgratinib NDA Accepted by NMPA for FGFR2+ Biliary Tract Cancer
SciClone Pharmaceuticals Inc. (HKG: 6600) announced that the National Medical Products Administration (NMPA) has accepted for...
Hengrui Pharma’s Trastuzumab Rezetecan Filing Accepted for HER2+ Colorectal Cancer Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
Takeda’s Oveporexton Wins FDA Priority Review for Narcolepsy Type 1, Potential First Orexin Agonist
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA)...
GSK’s RSV Vaccine Filing Accepted by NMPA for China Market Entry
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the Center for Drug Evaluation (CDE) of China’s NMPA...
Pfizer’s Cresemba Wins NMPA Pediatric Approval for Invasive Fungal Infections
Pfizer Inc. (NYSE: PFE) announced that the National Medical Products Administration (NMPA) has approved an indication...
Eli Lilly’s Omvoh Wins NMPA Approval for Crohn’s Disease and Ulcerative Colitis in China
The National Medical Products Administration (NMPA) has approved Eli Lilly and Company’s (NYSE: LLY) Omvoh (mirikizumab),...
Changchun High-Tech’s GenSci136 Wins NMPA Approval for IgA Nephropathy Clinical Trial
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun GeneScience...
Sanofi’s Wayrilz Wins FDA Breakthrough and Japan Orphan Designation for Rare Blood Disorder
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...
Eisai Biogen’s LEQEMBI Subcutaneous Autoinjector Wins NMPA Priority Review in China
Eisai Co., Ltd. and Biogen Inc. (NASDAQ: BIIB) announced that the Biologics License Application (BLA) for...
Huadong Medicine and Shian Biotech Advance siRNA Obesity Therapy to Preclinical Stage
Huadong Medicine Co., Ltd (SHE: 000963) announced a key milestone in its strategic collaboration with...
Delonix Bioworks’ DX-104 Becomes First China-Approved Engineered OMV Vaccine, Targets $1.3 Billion MenB Market
Delonix Bioworks announced that DX-104, its Group B meningococcal (MenB) vaccine candidate, has received clinical...
Sino Biopharm Completes Phase III Enrollment for LM-302 ADC in Gastric Cancer
Sino Biopharmaceutical Ltd (HKG: 1177) announced completion of patient enrollment for the registrational Phase III...