Gilead Sciences Secures FDA Accelerated Approval for Hepcludex as First US Treatment for Hepatitis Delta Virus
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Gilead Sciences, Inc. (NASDAQ:...
Product approvals
Daiichi Sankyo, AstraZeneca Secure FDA Approval for Datroway in Triple-Negative Breast Cancer After Phase III TROPION-Breast02 Success
Daiichi Sankyo Company, Limited (TYO: 4568) and AstraZeneca PLC (NYSE: AZN) announced U.S. Food and...
Hangzhou Diagens Secures NMPA Category III Approval for AI AutoVision Chromosome Karyotyping System
Hangzhou Diagens Biotechnology Co., Ltd. (HKG: 2526) announced it has received Category III medical device...
Qyuns Therapeutics and Huadong Medicine Secure NMPA Approval for Stelara Biosimilar HDM3001-2/QX001S in Crohn’s Disease
Qyuns Therapeutics (HKG: 2509) announced that HDM3001-2/QX001S, a biosimilar to Johnson & Johnson’s autoimmune therapy...
Yangtze River Pharma Secures NMPA Approval for Fazamorexant – Next-Generation DORA for Insomnia Treatment
Yangtze River Pharmaceutical Group (YRPG) announced that China’s National Medical Products Administration (NMPA) has granted...
Sino Medical Sciences Secures EU Label Update for HT Supreme Stent, Enabling One-Month Dual Antiplatelet Therapy
Sino Medical Sciences Technology Inc. (SHA: 688108) announced European Union regulatory approval for a label...
Mabwell Bioscience Secures Second NMPA Approval for Denosu Biosimilar, Expanding Indication to Bone Metastases and Multiple Myeloma
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received a second indication approval...
Shanghai ZJ Bio-Tech Secures International Approvals for Molecular Diagnostic Platforms in Netherlands and Mexico
Shanghai ZJ Bio-Tech Co., Ltd. (SHA: 688317), a leading Chinese molecular diagnostic reagent specialist, announced...
Bio-Thera Solutions Secures FDA Approval for Golimumab Biosimilars Immgolis and Immgolis Intri
Bio-Thera Solutions (SHA: 688177) announced it has received marketing approval from the U.S. Food and...
Boehringer Ingelheim’s JASCAYD (Nerandomilast) Approved in Japan for IPF and Progressive Pulmonary Fibrosis
Boehringer Ingelheim (BI) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted...
GSK’s Arexvy RSV Vaccine Receives Expanded Japanese Approval for Adults 18-49 at Increased Risk
GlaxoSmithKline plc (GSK) (NYSE: GSK) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW)...
AstraZeneca’s Baxfendy Secures FDA Approval for Uncontrolled Hypertension – First-in-Class Aldosterone Synthase Inhibitor with Selective CYP11B2 Targeting
AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has granted marketing...
AstraZeneca and Daiichi Sankyo’s ENHERTU Secures Dual FDA Approval for HER2-Positive Early Breast Cancer – Neoadjuvant and Adjuvant Indications Supported by Landmark Phase 3 Data
AstraZeneca (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug...
Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...
Shenzhen Salubris Secures Chinese Approval for Xinfutai Plus – First Once-Weekly Teriparatide for High-Risk Postmenopausal Osteoporosis
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced market approval from China’s National Medical Products...
Chipscreen Biosciences Secures Macao Market Approval for Bilessglu (Chiglitazar), Novel PPAR Pan-Agonist for Type 2 Diabetes
Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced it has received marketing clearance from the Pharmaceutical...
Basecare Medical Device Secures NMPA Approval for Gems Embryo Culture Medium – Chinese IVF Specialist Completes Global Regulatory Triad
Basecare Medical Device Co., Ltd. (HKG: 2170), a high-throughput sequencing-based assisted reproduction specialist, announced it...
Pfizer’s Hympavzi Gains European Approval for Hemophilia with Inhibitors – Novel TFPI-Targeting Therapy Offers Weekly Subcutaneous Alternative to Factor Replacement
Pfizer Inc. (NYSE: PFE) announced it has received European Commission (EC) approval for an indication...
BeOne Medicines’ BCL2 Inhibitor Beqalzi (Sonrotoclax) Receives FDA Fast Track for Relapsed Mantle Cell Lymphoma – 52% Response Rate in Phase I/II Study
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), formerly BeiGene, announced that its self-developed...
Roche Secures CE Mark for Elecsys pTau217 Blood Test, First Single-Assay Alzheimer’s Diagnostic with Amyloid Pathology Detection
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced on May 12, 2026, that it has received...