EMA Panel Recommends Brukinsa Tablet Formulation for Approval
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Drug
Sinocelltech Wins NMPA Clearance for TriAb SCTB39G in Solid Tumors
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received clearance from the National...
CARsgen’s Satri-cel NDA Accepted by China’s NMPA for Gastric Adenocarcinoma
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the National Medical Products Administration (NMPA)...
Lepu Biopharma Gains EMA Approval for MRG003 HNSCC Clinical Trial
China-based Lepu Biopharma Co., Ltd (HKG: 2157) announced that it has received approval from the...
Angel Pharma Gains NMPA Approval for Soquelitinib in Atopic Dermatitis Trial
China-based Angel Pharmaceuticals Ltd announced that it has received approval from the National Medical Products...
Biogen’s Phase I Results Highlight Salanersen’s Potential in Spinal Muscular Atrophy
Biogen (NASDAQ: BIIB) announced this week topline results from the Phase I study of salanersen...
Kymera and Sanofi Advance IRAK4 Program With Selection of KT-485 for Clinical Development
US-based Kymera Therapeutics Inc. (NASDAQ: KYMR) announced updates to its IRAK4-targeted program collaboration with Sanofi....
LG Chem’s Cross-Linked Sodium Hyaluronate Gel Gains NMPA Approval for Midface Use
South Korea’s LG Chem announced that its cross-linked sodium hyaluronate gel with lidocaine has received...
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)...
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...