Regent Pacific’s Senstend Receives NMPA Approval with Four-Year Data Protection, Triggering $5M Milestone Payment from Wanbang
Regent Pacific Group Limited (HKG: 0575) announced that the New Drug Application (NDA) for its...
Product approvals
Zelgen Biopharmaceuticals Secures NMPA Approval for Zepuping in Severe Alopecia Areata – First Immuno-Inflammatory Indication for Pan-JAK Inhibitor
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that the National Medical Products Administration (NMPA)...
BMS Secures NMPA Approval for Sotyktu in Psoriatic Arthritis – First Selective TYK2 Inhibitor Expands China Indications
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that China’s National Medical Products Administration (NMPA) has granted...
Fosun Pharma Secures NMPA Approval for Fumaining in Pediatric Langerhans Cell Histiocytosis – Expands MEK Inhibitor Franchise
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196; HKG: 2196) announced that China’s National Medical Products...
Gritpharma Secures NMPA Approval for Doxylamine as China’s First Novel Short-Term Insomnia Treatment
Nanjing Gritpharma Co., Ltd. announced it has received marketing approval from China’s National Medical Products...
Sanofi’s Tzield Receives FDA Approval to Preserve Insulin Production in Recently Diagnosed Type 1 Diabetes
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated...
Roche’s VENTANA PTEN Assay Receives FDA Approval as First Companion Diagnostic for AstraZeneca’s Truqap in Prostate Cancer
Roche Holding AG (SWX: ROP, OTCMKTS: RHHBY) announced that the VENTANA PTEN (SP218) RxDx Assay...
Merck Secures FDA Approval for Keytruda-Welireg Combination as Adjuvant Therapy in High-Risk Kidney Cancer
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...
Shouyao Holdings Secures NMPA Approval for Second-Generation ALK Inhibitor CT-707 as First-Line Treatment for ALK-Positive NSCLC
Shouyao Holdings (Beijing) Co., Ltd. (SHA: 688197), a Beijing-based pharmaceutical company, announced it has received...
Createrna’s MY008211A Becomes China’s First Home-Grown Oral CFB Inhibitor Approved for Paroxysmal Nocturnal Hemoglobinuria
Wuhan Createrna Science and Technology Co., Ltd., a China-based biopharmaceutical company, announced it has received...
Novartis Secures Fourth China Approval for Tafinlar-Mekinist Combo in BRAF V600E-Mutated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Novartis AG (NYSE: NVS) announced that China’s National Medical Products Administration (NMPA) has granted approval...
Akeso Biopharma Secures NMPA Approval for Gumokimab, IL-17A Monoclonal Antibody for Moderate-to-Severe Plaque Psoriasis
Akeso Biopharma (HKG: 9926) announced it has received marketing approval from China’s National Medical Products...
Bio-Thera Solutions Secures Singapore Approval for BAT2206, Biosimilar to J&J’s Stelara, Expanding Access Across Multiple Autoimmune Indications
Bio-Thera Solutions Ltd. (SHA: 688177) announced it has received marketing approval from Singapore’s Health Sciences...
NeuroGen Pharma Secures NMPA Approval for Ajovy (Fremanezumab) in China, Launching First Quarterly CGRP Migraine Prevention Therapy
NeuroGen Pharma announced it has received marketing approval from China’s National Medical Products Administration (NMPA)...
Henlius Biotech’s Serplulimab Becomes World’s First PD-1 Inhibitor Approved for Perioperative Gastric Cancer Treatment Following Landmark Phase III Results
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Eli Lilly Secures FDA Approval for Every-Eight-Week EBGLYSS Regimen in Atopic Dermatitis, Offering Just Six Annual Injections
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA)...
Shanghai Bio-heart Secures Israeli Registration for Iberis RDN System – World’s Only Dual-Access Renal Denervation Platform
Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced it has received regulatory approval for...
Jikeshu (Sebaloxavir Marboxil) Receives NMPA Approval for Adolescent Influenza Treatment, Expanding Single-Dose Category 1 Antiviral Franchise
Jikeshu (sebaloxavir marboxil), a Category 1 anti-influenza drug jointly developed by Jumpcan Pharmaceutical (SHA: 600566)...
European Commission Approves Sanofi’s Subcutaneous Sarclisa (Isatuximab) Across All Multiple Myeloma Indications Based on Phase III IRAKLIA Data
The European Commission announced this week its approval of Sanofi’s (NASDAQ: SNY) Sarclisa (isatuximab) subcutaneous...
RemeGen Secures Dual NMPA Approvals for Tai’ai (Telitacicept) in Sjögren’s Syndrome and IgA Nephropathy, Expanding First-in-Class BLyS/APRIL Inhibitor Franchise
RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) announced today that China’s National Medical Products Administration...