Gene Cradle’s GC310 Receives Tacit Approval from NMPA for Wilson’s Disease
Beijing-based gene therapy specialist Gene Cradle announced that it has received tacit clinical approval from...
Drug
Hanx Biopharmaceuticals Gains NMPA Approval for HX044 Clinical Trials
China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clinical trial approval from...
Likang Life Sciences Gains FDA Approval for LK101 Clinical Trials
Beijing-based cell therapy developer Likang Life Sciences announced that it has received approval from the...
EMA Committee Backs Subcutaneous Rybrevant for Lung Cancer Treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Akeso Completes Enrollment for Global Phase III Trial of Ivonescimab in Lung Cancer
China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global...
Bayer Files for EMA Approval of Kerendia for Heart Failure
Bayer AG (FRA: BAYN) announced that it has made another market filing with the European...
Sino Biopharmaceutical’s Tulobuterol Patch Gains NMPA Approval
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its subsidiary Beijing Tide Pharmaceutical Co., Ltd...
Astellas Pharma Submits NDA for Avacincaptad Pegol in Japan for Geographic Atrophy
Japan-based major Astellas Pharma (TYO: 4503) announced that it has submitted a New Drug Application...
Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US...
FDA Approves Enhertu for HER2-Low and HER2-UltraLow Breast Cancer
The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody...
Betta Pharmaceuticals Gains NMPA Approval for BPI-452080 Clinical Study
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received approval from the...
Haisco’s HSK39004 Gains NMPA Approval for COPD Clinical Trials
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that it has received clinical trial...
Junshi Biosciences Receives NMPA Approval for JS213 Clinical Trials
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received...
Beijing Biostar’s Utidelone Gains FDA Approval for Global Phase II/III Study
China’s Beijing Biostar Technologies Ltd (HKG: 2563) announced that it has received approval from the...
Harbour BioMed Receives NMPA Clearance for COPD Treatment HBM9378/SKB378
China-based biopharmaceutical company Harbour BioMed (HKG: 2142) has announced receiving clinical clearance from China’s National...
IASO Bio’s CAR-T Therapy Fucaso Accepted for Review in Singapore
China-based IASO Biotherapeutics has announced that a New Drug Application (NDA) for its BCMA-targeted chimeric...
China’s MoC Lists US Firms PVH and Illumina as Unreliable Entities
China’s Ministry of Commerce (MoC) has released a list of unreliable entities, including US firms...
MediLink Therapeutics’ YL217 Receives FDA IND Clearance for Novel ADC Targeting Gastrointestinal Cancers
MediLink Therapeutics, a clinical-stage biotech company, announced today that its internally developed antibody-drug conjugate (ADC),...
Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug...
FDA Clears sBLA for Eisai and Biogen’s Leqembi Maintenance Dosing
Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the...