Hengrui’s Rezvilutamide Receives EMA Acceptance for Metastatic Prostate Cancer Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the European Medicines Agency...
Market approval filings
Roche’s Lunsumio-Polatuzumab Combination Accepted for FDA Review in Relapsed/Refractory Large B-Cell Lymphoma
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration...
CSPC Pharmaceutical’s Efmedaglutide Alfa GLP-1 Therapy Accepted for NMPA Review in Type 2 Diabetes Indication
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has...
CSPC Pharmaceutical’s Cosentyx Biosimilar Accepted for NMPA Review in China’s Competitive IL-17A Market
CSPC Pharmaceutical Group (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted...
Gilead Sciences Submits sNDA for Once-Weekly Oral Yeztugo PrEP – Potential First Long-Acting Oral HIV Prevention Option
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has...
Sichuan Biokin’s Iza-Bren Becomes World’s First EGFR×HER3 Bispecific ADC with NDA Accepted by China’s NMPA
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that the new drug application (NDA) for...
Hansoh Pharmaceutical’s NDA for HS-10568 Calcium-Sensing Receptor Modulator Accepted by China’s NMPA for Secondary Hyperparathyroidism in Dialysis Patients
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA)...
Haisco Pharmaceutical Files Nav1.8 Inhibitor HSK51155 with NMPA Following $700M+ AbbVie Licensing Deal for Novel Pain Therapeutic
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced it has submitted a clinical filing for...
Huadong Medicine’s Ellansé S Dermal Filler Receives NMPA Acceptance for Forehead Contouring Indication, Expanding China’s Premium Aesthetic Portfolio
Huadong Medicine Co., Ltd. (SHE: 000963) announced that the National Medical Products Administration (NMPA) has...
Shanghai Bao Pharmaceuticals’ KJ103 NDA Accepted by NMPA – First-in-Class IgG Degrading Enzyme for Highly Sensitized Kidney Transplant Patients
Shanghai Bao Pharmaceuticals Co., Ltd. (HKG: 2659) announced that the National Medical Products Administration (NMPA)...
Innovent Biologics Reports Positive Phase III Results for IBI343 in Advanced Gastric Cancer – CLDN18.2-Targeting ADC Files NDA with NMPA
Innovent Biologics (HKG: 1801) announced that the pre-specified first interim analysis from the global Phase...
Hansoh Pharmaceutical’s Olatorepatide GLP-1/GIP Dual Agonist Accepted for NMPA Review for Weight Management Indication
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA)...
Medtronic Submits FDA 510(k) Filings to Expand Hugo RAS System into General and Gynecologic Surgery, Adds LigaSure Maryland Instrument
Medtronic plc (NYSE: MDT) announced on June 3, 2026, the submission of 510(k) premarket notifications...
Roche’s Oral SERD Giredestrant Receives FDA Priority Review for Early Breast Cancer Adjuvant Treatment
Roche Holding AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration...
BMS’ Camzyos Receives FDA Priority Review for Adolescent Obstructive HCM Treatment
Bristol-Myers Squibb Co. (BMS, NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA)...
Livzon Pharmaceutical Secures NMPA Approval for LZM012/XKH004, China’s First IL-17A/F Dual Inhibitor for Ankylosing Spondylitis
Livzon Pharmaceutical Group Inc. (HKG: 1513) announced it has received marketing approval from China’s National...
Shandong Boan Submits Dual Denosumab Biosimilar BLAs to FDA for Osteoporosis and Oncology Indications
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of Biologics License Applications (BLAs)...
InnoCare Pharma’s BTK Inhibitor Orelabrutinib Gains NMPA Review Acceptance for Primary Immune Thrombocytopenia Indication
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced that the Center for Drug Evaluation (CDE)...
Pierre Fabre Secures EU Recommendation for Braftovi Combo in First-Line BRAF V600E-Mutant Metastatic Colorectal Cancer
Pierre Fabre Laboratories announced that the European Medicines Agency’s Committee for Medicinal Products for Human...
Henlius Biotech’s PD-1 Inhibitor Hetronifly Receives CHMP Recommendation for Squamous NSCLC in EU
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s Committee for Medicinal...