Takeda Secures World’s First NMPA Approval for Orexatone – Novel Oral OX2R Agonist for Type 1 Narcolepsy
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that China’s National Medical Products Administration...
Product approvals
Eisai and Biogen Secure FDA Approval for LEQEMBI Subcutaneous Autoinjector for Early Alzheimer’s Disease Initiation
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) jointly announced that the U.S....
Easton Pharmaceutical Secures NMPA Approval for China’s First Generic Remimazolam Besylate, Challenging Humanwell’s Ruima Monopoly in Procedural Sedation and General Anesthesia
Easton Pharmaceutical Co., Ltd (SHA: 688513) announced that its generic version of remimazolam besylate has...
Bio-Sincerity Secures NMPA Approval for Levetiracetam Extended-Release Granules – Pediatric-Friendly Epilepsy Treatment for Patients with Swallowing Difficulties
Hangzhou Bio-Sincerity Pharma-tech Corp., Ltd (SHE: 301096) announced that its Category 2.2 modified drug Levetiracetam...
Allergan Aesthetics Secures European Commission Approval for Boey (trenibotulinumtoxinE) – First Rapid-Onset, Short-Duration Botulinum Neurotoxin Serotype E for Glabellar Lines
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that the European Commission has approved Boey...
Sichuan Biokin’s Yizekang Receives NMPA Approval as World’s First EGFR×HER3 Bispecific ADC for Esophageal Squamous Cell Carcinoma
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...
Novartis’ Fabhalta Receives FDA Approval as First Oral Complement Factor B Inhibitor to Slow Renal Decline in Primary IgA Nephropathy
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted...
Merck’s Lipfendra Receives FDA Approval as First Oral PCSK9 Inhibitor for LDL Cholesterol Reduction in Hypercholesterolemia Patients
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...
Novo Nordisk Secures EU Approval for Wegovy Pill, First Oral Semaglutide 25mg for Obesity Treatment
Novo Nordisk (NYSE: NVO) announced today that the European Commission (EC) has granted marketing authorization...
Innovent Biologics Secures Macau Approval for Dual-Immunotherapy Neoadjuvant Regimen in MSI-H/dMMR Colon Cancer
Innovent Biologics (HKG: 1801) announced that its independently developed Daboxin (ipilimumab N01) has received marketing...
Sanofi Secures FDA Approval for Sarclisa Escena Subcutaneous Formulation, First Dual-Administration Anti-Cancer Therapy for Multiple Myeloma
Sanofi S.A. (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has approved...
Roche Secures CE Mark for Elecsys IGRA TB Test, Delivering Automated Solution for Tuberculosis Infection Detection
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced that its Elecsys IGRA TB test has...
Johnson & Johnson Secures FDA Approval for Dual Energy THERMOCOOL SMARTTOUCH SF Platform, First Single-Catheter Solution Combining Radiofrequency and Pulsed Field Ablation
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA)...
AbbVie Secures European Commission Approval for TEPKINLY Combination Therapy in Relapsed/Refractory Follicular Lymphoma with 79% Reduction in Disease Progression Risk
AbbVie Inc. (NYSE: ABBV) announced that the European Commission (EC) has granted marketing authorization for...
Novartis Secures EU Approval for Itvisma, First Gene Replacement Therapy for Broad SMA Population Including Patients Two Years and Older
Novartis AG (NYSE: NVS) announced that the European Commission (EC) has granted marketing authorization for...
Ocumension Therapeutics Secures NMPA Approval for OT-502, China’s First Single-Dose Sustained-Release Intraocular Steroid for Postoperative Inflammation
Ocumension Therapeutics (HKG: 1477) announced that China’s National Medical Products Administration (NMPA) has approved the...
Hangzhou Adamerck’s Aom0498 Receives NMPA Approval as China’s First Homegrown Neuromuscular Blockade Reversal Agent – Completing Decade-Long National Innovation Program
Hangzhou Adamerck Pharmlabs Inc. announced that its independently developed Class 1 innovative drug Aom0498 has...
Jingxin Pharmaceutical Secures NMPA Approval for China’s First Generic Cariprazine in Schizophrenia – Capturing Market Opportunity as Reference Product Remains Unlaunched
Jingxin Pharmaceutical (SHE: 002020) announced that China’s National Medical Products Administration (NMPA) has approved the...
Innovative Medical Management Subsidiary Cereblink Secures Registration for AM5 Upper Limb Rehabilitation Exoskeleton – EMG-Driven System Targets CNS Injury Recovery
Innovative Medical Management Co., Ltd. (SHE: 002173) announced that its holding subsidiary Cereblink (Hangzhou) Technology...
Hua Medicine Completes Greater China Rollout as Dorzagliatin Gains Macau Approval – First-in-Class Glucokinase Activator Now Available Across All Chinese Territories
Hua Medicine (HKG: 2552) announced that the Pharmaceutical Administration Bureau of the Macau Special Administrative...