Eli Lilly’s Amyvid Sees FDA-Approved Label Update for Alzheimer’s Diagnosis
US-based Eli Lilly & Co. (NYSE: LLY) announced the US Food and Drug Administration (FDA)...
Drug
SineuGene’s ALS Gene Therapy SNUG01 Granted FDA Orphan Drug Designation
Beijing-based SineuGene Therapeutics, a developer of gene therapies for brain disorders, announced this week that...
Acotec Scientific Wins NMPA Approval for Armoni-HP Balloon Catheter
China-based Acotec Scientific Holdings Ltd (HKG: 6669) announced that it has received marketing approval from...
Genevector’s JWK002 Gains NMPA IND Approval for XLRS Gene Therapy
China-based Chengdu Geneector Biotechnology Co., Ltd. (Genevector), a developer of AAV gene therapy drugs, announced...
Livzon’s YJH-012 siRNA Drug Gets NMPA Green Light for Gout Trials
China-based Livzon Pharmaceutical Group Inc., (HKG: 1513) announced that its Category 1 chemical drug YJH-012...
Lundbeck’s Lu AG13909 Wins Orphan Drug Designations for Congenital Adrenal Hyperplasia
Denmark-based pharmaceutical company Lundbeck A/S (OTCMKTS: HLUBF) announced that it has received Orphan Drug Designations...
Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing...
C.Q. Pharma’s Prasugrel Clinical Filing Accepted by China’s NMPA
China-based C.Q. Pharmaceutical Holding Co., Ltd (SHE: 000950) announced that its clinical application for prasugrel...
BeOne Medicines Launches Ziihera for HER2-High Biliary Tract Cancer in China
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced the official commercial availability...
GSK Gains FDA Clearance for Benlysta Autoinjector in Pediatric Lupus Nephritis
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received clearance from the US Food...
Medilink Therapeutics’ YL201 Wins FDA Breakthrough Therapy Designation for SCLC
Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US...
FDA Approves AstraZeneca’s Datopotamab deruxtecan for EGFR-Mutated NSCLC
The US Food and Drug Administration (FDA) this week approved Datopotamab deruxtecan (Dato-DXd), a TROP-2-targeted...
TransThera Sciences’ Tinengotinib Gains FDA Fast Track for mCRPC Treatment
China-headquartered TransThera Sciences (Nanjing) Inc., (HKG: 2617), which listed in Hong Kong this week, announced...
XtalPi Signs LOI With DoveTree for AI-Powered Drug Development
Shenzhen-based QuantumPharm Inc., known as Xtalpi Inc. (HKG: 2228), announced the signing of a Letter...
Merck’s Prevymis Approved in China for Pediatric CMV Prevention
US-based pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that its novel non-nucleoside...
Sansure Biotech Wins NMPA Approval for Fungal Infection Detection Kit
China’s National Medical Products Administration (NMPA) has approved Sansure Biotech Inc.’s (SHA: 688289) Pneumocystis jirovecii,...
Vcanbio Submits Clinical Trial Application for VUM02 in Severe Pneumonia Treatment
China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) announced that its clinical trial...
Simcere Halts R&D on Alzheimer’s Drug Candidates Amid Pipeline Setbacks
Simcere Pharmaceutical Group (HKG: 2096) has reportedly discontinued research and development of its Alzheimer’s disease...
Yifan Pharma Wins NMPA Approval for Norditropin Biosimilar Trial
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced that it has received clinical trial approval...
GSK’s Linerixibat Accepted for EMA Review for Cholestatic Pruritus in PBC
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted the...