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...
Product approvals
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...
NMPA Approves Hangzhou Biosunpharma’s Bewintinib as First-Line JAK2 Inhibitor for Myelofibrosis with 62.8% Spleen Volume Response Rate
China’s National Medical Products Administration (NMPA) has granted approval to Hangzhou Biosunpharma Co., Ltd. for...
Avistone Biotechnology’s Andatinib Receives China Conditional Approval for EGFR Ex20ins NSCLC
Beijing Avistone Biotechnology Co., Ltd. announced that its self-developed EGFR exon 20 insertion (ex20ins) inhibitor,...
Suzhou Basecare Medical Secures China’s First NMPA Approval for Thalassemia Preimplantation Genetic Testing Kit
Suzhou Basecare Medical Co., Ltd. (HKG: 2170) announced that China’s National Medical Products Administration (NMPA)...
Abbott Secures FDA Clearance and CE Mark for Ultreon 3.0 AI-Powered OCT Imaging Platform
Abbott (NYSE: ABT) announced it has received U.S. Food and Drug Administration (FDA) clearance and...
Henlius Biotech Secures European Commission Approval for Poherdy Biosimilar to Roche’s Perjeta
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received marketing authorization from the European...
Novartis Secures European Commission Approval for Rhapsido (remibrutinib) in Chronic Spontaneous Urticaria – Expanding Global BTK Inhibitor Franchise
Novartis AG (NYSE: NVS) announced on April 27, 2026, that the European Commission (EC) has...
AstraZeneca Secures FDA Approval for Subcutaneous Saphnelo in Systemic Lupus Erythematosus After Addressing Supplemental Data Request
AstraZeneca plc (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved...
AstraZeneca Secures Dual NMPA Approvals for Imfinzi-Based Regimens in Advanced Hepatocellular Carcinoma and NSCLC
AstraZeneca plc (NYSE: AZN) announced that China’s National Medical Products Administration (NMPA) has granted approvals...
Huadong Medicine Secures NMPA Approval for Ellansé M PCL Microsphere Filler for Temple Hollowing Correction
Huadong Medicine Co., Ltd. (SHE: 000963) announced it has received marketing approval from China’s National...
Regeneron Secures FDA Approval for Otarmeni Gene Therapy and Announces Landmark U.S. Pricing Agreement
Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...
FDA Expands Sanofi’s Tzield Approval to Children as Young as One Year Old for Type 1 Diabetes Prevention
The U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application for...
European Commission Grants Conditional Approval to Ipsen’s Ojemda (Tovorafenib) for Pediatric Low-Grade Glioma with BRAF Alterations
Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced on April 22, 2026, that the European Commission...
Johnson & Johnson Secures CE Mark for Advanced ETHICON 4000 Surgical Stapler with Proprietary 3D Stapling Technology
Johnson & Johnson (J&J, NYSE: JNJ) announced on April 22, 2026, that it has received...
FDA Approves Sanofi-Regeneron’s Dupilumab for Pediatric Chronic Spontaneous Urticaria in Children Aged 2–11 Years
The U.S. Food and Drug Administration (FDA) has granted approval to Sanofi (NASDAQ: SNY) and...