Novo Nordisk’s Wegovy Granted FDA Approval for Metabolic-Associated Steatohepatitis
Danish biopharmaceutical giant Novo Nordisk A/S (NYSE: NVO) announced on August 15, 2025, that its...
Product approvals
FDA Accelerates Approval of Dordaviprone for H3 K27M-Mutant Diffuse Midline Glioma
The U.S. Food and Drug Administration (FDA) granted accelerated approval on August 6, 2025, to...
FDA Approves Precigen’s Papzimeos for Recurrent Respiratory Papillomatosis”
The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba), developed by Precigen,...
Novartis’ Leqvio Approved by FDA as Standalone Therapy for Hypercholesterolemia
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced on August 12, 2025, that the U.S. Food...
J&J MedTech Gains China Approval for MENTOR MemoryGel Xtra Breast Implants
US major Johnson & Johnson MedTech announced that its MENTOR MemoryGel Xtra Breast Implants have...
Shandong Boan’s Boyouping Receives NMPA Approval for Type 2 Diabetes Treatment
Shandong Boan Biotechnology Co., Ltd (HKG: 6955) announced on August 8, 2025, that its self-developed...
Boehringer Ingelheim’s HERNEXEOS Receives FDA Accelerated Approval for NSCLC Treatment
German pharmaceutical giant Boehringer Ingelheim (BI) announced that its HERNEXEOS (zongertinib tablets) has received accelerated...
Johnson & Johnson’s Rybrevant Approved by China’s NMPA for EGFR-Mutant NSCLC Treatment
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that China’s National Medical Products Administration...
Teleflex’s Rüsch EZ-Blocker Gets NMPA Approval for China Market
US-based Teleflex Incorporated (NYSE: TFX) announced that its Rüsch EZ-Blocker single-use bronchial blocker has received...
Cryofocus Medtech’s Cryoadhesion System Gains NMPA Approval for Commercialization
Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922) announced that it has received approval from China’s...
AstraZeneca’s Fasenra Approved for Pediatric Severe Eosinophilic Asthma in China
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced the official approval of a new indication...
Sino Biopharmaceutical’s Rovadicitinib Granted Breakthrough Therapy Designation for Chronic Graft-versus-Host Disease
China-based Sino Biopharmaceutical Limited (HKG: 1177) announced that its self-developed JAK/ROCK dual small molecule inhibitor,...
Everest Medicines’ Nefecon Granted Full Approval by Taiwan’s TFDA for IgA Nephropathy
China-based Everest Medicines (HKG: 1952) announced today that the Taiwan Food and Drug Administration (TFDA)...
CSPC Pharmaceutical’s Semaglutide Injection NMPA Marketing Application Accepted
China-based CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the marketing application for its semaglutide...
Gaush Meditech’s Frequency-Domain Biometer Gains Medical Device Registration in Jiangsu
Suzhou-based Gaush Meditech Ltd (HKG: 2407) has recently obtained the medical device registration certificate for...
Zhaoke Ophthalmology’s TONO-i Gains NMPA Approval for Glaucoma Management in China
China-based Zhaoke Ophthalmology Limited (HKG: 6622) announced that its innovative product, TONO-i, has received a...
Cutia Therapeutics’ CU-40102 Approved in Hong Kong for Androgenetic Alopecia Treatment
China-based dermatology specialist Cutia Therapeutics (HKG: 2487) announced today that its CU-40102 (finasteride topical spray)...
Lee’s Pharma’s Socazolimab Approved by NMPA for ES-SCLC First-Line Treatment
Lee’s Pharmaceutical Holdings Ltd. (HKG: 0950) announced that its in-licensed programmed-death ligand 1 (PD-L1) monoclonal...
BeOne Medicines’ BGB-16673 Granted PRIME Designation by EMA for Waldenström’s Macroglobulinemia
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced on July 31, 2025,...
AstraZeneca’s Ultomiris Gains NMPA Approval for Neuromyelitis Optica Spectrum Disorder
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that China’s National Medical Products Administration (NMPA)...