AbbVie Secures FDA Approval for DECNUPAZ in Blastic Plasmacytoid Dendritic Cell Neoplasm – First CD123-Targeting ADC Addresses Ultra-Rare Hematologic Malignancy
AbbVie Inc. (NYSE: ABBV) announced on May 27, 2026, that the U.S. Food and Drug...
Product approvals
InnoCare Pharma Secures Australian TGA Approval for Hibruka in Relapsed/Refractory Mantle Cell Lymphoma – Highly Selective BTK Inhibitor Expands International Footprint
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced that Australia’s Therapeutic Goods Administration (TGA) has...
MicroPort NeuroTech Secures FDA Approval for NUMEN Helia Spring Coil System – Advanced Solution for Complex Neurovascular Lesions
MicroPort NeuroTech Limited (HKG: 2172) announced it has received marketing approval from the U.S. Food...
Lupin Secures NMPA Approval for Oseltamivir Phosphate in China Through Yabao Pharmaceuticals Partnership
Lupin Limited (NSE: LUPIN) announced that China’s National Medical Products Administration (NMPA) has approved its...
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:...
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...