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...
Product approvals
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...
Merus’ Bizengri Becomes First FDA-Approved Therapy for NRG1 Fusion-Positive Cholangiocarcinoma
The U.S. Food and Drug Administration (FDA) granted approval to Merus N.V.’s Bizengri (zenocutuzumab-zbco) for...
Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from...
MicroPort CardioFlow Secures CE Mark for ENO Series Pacemakers with Advanced LBBAP Capability
MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of MicroPort Scientific Corp (HKG: 0853),...
European Commission Approves Bristol Myers Squibb’s Sotyktu for Psoriatic Arthritis Following FDA Clearance
The European Commission (EC) granted marketing authorization this week for Bristol-Myers Squibb‘s (BMS, NYSE: BMY)...
Sino Biopharmaceutical’s Subsidiary Tianqing Secures Expanded NMPA Approval for Saitanxin – First-in-Class CDK2/4/6 Inhibitor Moves to First-Line Breast Cancer
Chia Tai Tianqing Pharmaceutical Group, a wholly owned subsidiary of Sino Biopharmaceutical Ltd. (HKG: 1177),...
Cutia Therapeutics Secures NMPA Approval for CU-30101 Topical Anesthetic Cream – Dermatology Specialist Expands Commercial Portfolio
Cutia Therapeutics (HKG: 2487), a dermatology-focused specialty pharmaceutical company, announced that China’s National Medical Products...
Amgen Secures NMPA Approval for Evenity (Romosozumab) – Novel Osteoporosis Treatment for High-Risk Postmenopausal Women in China
Amgen Inc. (NASDAQ: AMGN) announced that China’s National Medical Products Administration (NMPA) has granted marketing...