FDA Approves GSK’s Wellcovorin for Cerebral Folate Deficiency – First Treatment for Rare FOLR1 Genetic Disorder
The U.S. Food and Drug Administration (FDA) approved expanded use of GlaxoSmithKline’s (GSK, NYSE: GSK)...
Product approvals
Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis
Bristol-Myers Squibb (BMS, NYSE: BMY) announced FDA approval for a label extension of Sotyktu (deucravacitinib),...
Novo Nordisk’s IcoSema Wins NMPA Approval – Once-Weekly Insulin-Semaglutide Combo Targets China Type 2 Diabetes Market
Novo Nordisk A/S (NYSE: NVO) secured NMPA approval for IcoSema, a once-weekly fixed-dose combination of...
Sciwind’s Ecnoglutide Wins NMPA Approval for Weight Loss – World’s First cAMP-Biased GLP-1 Agonist Targets China Obesity Market
Sciwind Biosciences announced that Ecnoglutide injection (Xianweiying), the world’s first cAMP-biased GLP-1 receptor agonist, has...
J&J’s TECVAYLI Wins FDA Approval in Earlier-Line Myeloma – BCMA BiTE Plus Daratumumab Combo Expands Addressable Market
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA)...
Sanyou Medical’s 3D‑Printed SWINGO-3D Lumbar Cage Wins FDA 510(K) – Advances Spinal Fusion Technology
Sanyou Medical (SHA: 688085) announced that its French subsidiary Implanet has received FDA 510(K) clearance for...
Sihuan Pharma’s Bireociclib Wins NMPA Approval for First‑Line HR+/HER2‑ Breast Cancer – CDK2/4/6 Inhibitor Expands Label
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that Xuanyuening (bireociclib), a Category 1 CDK2/4/6 inhibitor developed...
Bio-Thera’s Stelara Biosimilar Usymro Wins UK Approval – Expands European Market Access via Gedeon Richter
Bio-Thera Solutions Ltd (SHA: 688177) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)...
Asieris Pharma’s Cevira Wins NMPA Approval – World’s First Non‑Surgical Photodynamic Therapy for Cervical Lesions
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176), a urogenital cancer specialist, announced marketing approval from China’s...
Hua Medicine’s Dorzagliatin Wins Hong Kong Approval – First‑in‑Class GKA Enters Market for Type 2 Diabetes
Hua Medicine (HKG: 2552) announced that the Department of Health in Hong Kong has approved HuaTangNing...
Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis
Sino Biopharmaceutical Limited (HKG: 1177) announced that the National Medical Products Administration (NMPA) has approved rovadicitinib...
Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China
Zhejiang Hangyu Pharmaceutical Co., Ltd., a subsidiary of Jemincare, announced that China’s National Medical Products...
Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion
Sanofi (NASDAQ: SNY) announced that Dupixent (dupilumab) has been approved by China’s National Medical Products Administration...
Olumiant Wins CHMP Positive Opinion for Pediatric Alopecia – JAK Inhibitor Nears EU Approval for Teens with Severe AA
Eli Lilly (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the European Medicines Agency’s (EMA) Committee for...
FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track
The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...
FDA Approves AstraZeneca’s Calquence Plus Venetoclax for CLL/SLL – First All‑Oral Fixed‑Duration Regimen
AstraZeneca (AZ, NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved the...
Dupixent Wins FDA Approval for Allergic Fungal Rhinosinusitis – First Targeted Therapy for AFRS Expands Dupilumab Label
Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...
CanSino Biologics Wins NMPA Approval for Menhycia Age Expansion – MCV4 Now Covers Children Up to 6 Years
CanSino Biologics (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has approved a supplementary...
J&J’s RYBREVANT SC Dosing Approved by EC – Expands Subcutaneous Options Across All NSCLC Indications
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved an extension...
Sino Biopharma’s Benmelstobart Secures Fourth NMPA Approval for Stage III NSCLC – Expanding PD‑L1 Franchise in China
Sino Biopharmaceutical Limited (HKG: 1177) announced that benmelstobart, a Category 1 innovative humanized anti‑PD‑L1 monoclonal antibody...