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...
Product approvals
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...
Zai Lab Secures NMPA Approval for Tivdak (Tisotumab Vedotin) in Recurrent or Metastatic Cervical Cancer Based on Phase III innovaTV 301 Data
Zai Lab (NASDAQ: ZLAB; HKG: 9688) announced today that China’s National Medical Products Administration (NMPA)...
Otsuka Pharmaceutical Secures NMPA Approval for Voyxact (Sibeprenlimab) in IgA Nephropathy Based on Pivotal Phase III VISIONARY Data
Otsuka Pharmaceutical Co., Ltd. (OTCMKTS: OTSKY) announced today that China’s National Medical Products Administration (NMPA)...
Pfizer Secures FDA Approval for Marstacimab Expanded Indication in Hemophilia A and B Across Pediatric and Adult Populations
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has...
Sino Medical Sciences Secures Colombian Approval for HT Supreme Drug-Eluting Stent – Advanced Dual-Polymer Technology Expands Latin American Presence
Sino Medical Sciences Technology Inc. (SHA: 688108) announced it has received marketing approval from Colombia’s...