Kelun-Biotech Submits New NMPA Filing for Jaitailai in First-Line NSCLC Combination Therapy with Keytruda
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced it has submitted a new indication approval...
Market approval filings
Huadong Medicine’s Asthma Drug CXG87 Receives NMPA Filing Acceptance Following Successful Phase III Trial Against Symbicort
Huadong Medicine Co., Ltd. (SHE: 000963) announced that the National Medical Products Administration (NMPA) has...
Wuhan YZY Biopharma’s Bispecific Antibody M701 Receives NMPA Acceptance for Review in Malignant Ascites Treatment
Wuhan YZY Biopharma Co., Ltd. (HKG: 2496) announced that the National Medical Products Administration (NMPA)...
AstraZeneca’s Truqap Receives Positive ODAC Recommendation for PTEN-Deficient mHSPC Based on CAPItello-281 Trial Data
AstraZeneca plc (NYSE: AZN) announced that the US Food and Drug Administration’s (FDA) Oncologic Drugs...
Gilead’s Investigational HIV Regimen BIC/LEN Receives FDA Acceptance for Review with Decision Expected August 2026
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has...
HutchMed’s Sovleplenib Granted NMPA Priority Review for Warm Antibody Autoimmune Hemolytic Anemia
HutchMed (China) Limited (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
AbbVie Submits FDA Application for RINVOQ in Severe Alopecia Areata – Expanding JAK Inhibitor Franchise
AbbVie Inc. (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to...
AbbVie Submits FDA Filing for Skyrizi Subcutaneous Induction Therapy in Crohn’s Disease – Expanding IL-23 Inhibitor Franchise
AbbVie (NYSE: ABBV) announced it has submitted a marketing approval filing to the U.S. Food...
Sanofi Secures CHMP Positive Opinion for Cenrifki (Tolebrutinib) in Non-Relapsing SPMS Despite FDA Complete Response Letter Setback
Sanofi (NASDAQ: SNY) announced on 24 April 2026 that the European Medicines Agency’s Committee for...
China Medical System’s Comekibart Anti-IL-4Rα Antibody Enters NMPA Review for Seasonal Allergic Rhinitis
China Medical System Holdings Limited (CMS; HKG: 0867) announced that the National Medical Products Administration...
FDA Extends Review Timeline for Sanofi’s Sarclisa Subcutaneous Formulation by Three Months; New Decision Date Set for July 23, 2026
The U.S. Food and Drug Administration (FDA) has extended the target action date for its...
FDA Grants Priority Review to Merck, Astellas, and Pfizer’s sBLA for Padcev-Pembrolizumab Combo in Perioperative Muscle-Invasive Bladder Cancer
Merck & Co. (MSD, NYSE: MRK), Astellas Pharma (TYO: 4503), and Pfizer Inc. (NYSE: PFE)...
Huadong Medicine’s Semaglutide Biosimilar HDM1702 Enters NMPA Review for Weight Management Indication
Huadong Medicine Co., Ltd. (SHE: 000963) announced that the National Medical Products Administration (NMPA) has...
Beijing Sinotau’s Prostate Cancer Diagnostic Agent XTR020 Receives NMPA Review Acceptance
Beijing Sinotau International Pharmaceutical Technology Co., Ltd., a specialized nuclear medicine enterprise, announced that the...
FDA Accepts NDA for Telix’s Pixclara (TLX101-Px) Glioma Imaging Agent, Decision Expected September 2026
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX), the Australian partner of Grand Pharmaceutical Group Co.,...
Duality Biologics Files NMPA Market Approval for DB-1303 HER2 ADC – Phase III Study Beats T-DM1 in Metastatic Breast Cancer
Duality Biologics (HKG: 9606), a US‑China dual‑headquartered antibody‑drug conjugate (ADC) developer, announced that the National Medical...
Lynk Pharmaceuticals’ JAK1 Inhibitor Zemprocitinib Enters NMPA Review for Atopic Dermatitis
Lynk Pharmaceuticals Co., Ltd., a clinical-stage Chinese biopharmaceutical company, announced that the National Medical Products...
Duality Biologics’ HER2-Targeted ADC DB-1303 (BNT323) Enters NMPA Review for Metastatic Breast Cancer
Duality Biologics Co., Ltd. (HKG: 9606), a U.S.-China biotech specializing in antibody-drug conjugates (ADCs), announced...
Teva Secures FDA Approval for Prolia Biosimilar Ponlimsi, Advances Xolair Copycat Through Regulatory Channels
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has announced FDA marketing approval for Ponlimsi, its biosimilar...
GSK’s Bepirovirsen Receives EMA Review Acceptance for Chronic Hepatitis B, Pioneering Triple-Mechanism ASO Therapy
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted for...