HutchMed’s Orpathys Approved in China for EGFR-MET Co-Mutation NSCLC
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that it has received marketing approval from...
Product approvals
Hengrui Pharmaceuticals’ Aihengping Gains NMPA Approval for Regional Analgesia
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received marketing approval...
Avistone’s Vebreltinib Wins NMPA Approval for MET-Amplified NSCLC
Beijing Avistone Pharmaceuticals Biotechnology Co., Ltd. announced that its subsidiary Pearl Bio’s c-MET inhibitor vebreltinib...
Hengrui Pharmaceuticals Gains NMPA Approval for Aisuda in Severe Alopecia Areata
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received additional indication approval from the...
MicroPort NeuroTech’s NUMEN Nest Gains FDA Marketing Approval
China-based MicroPort NeuroTech Limited (HKG: 2172) announced that its NUMEN Nest, an enhanced version of...
BMS Secures FDA Approval for Updated Labels of Breyanzi and Abecma
US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the US Food and Drug Administration...
Pfizer’s Emblaveo Approved by China’s NMPA for Complex Infections
US giant Pfizer Inc., (NYSE: PFE) announced that it has received marketing approval from China’s...
Gilead’s Lenacapavir Approved in Hainan for HIV-1 Pre-Exposure Prophylaxis
US-based Gilead Sciences, Inc. (NASDAQ: GILD) announced that its HIV pre-exposure prophylaxis (PrEP) drug, lenacapavir,...
Sino Biopharmaceutical’s LM-108 Gains CDE BTD for Gastric Adenocarcinoma
Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has obtained Breakthrough Therapy Designation (BTD) from...
Fosun Pharma’s Serplulimab Approved for ES-SCLC in the UK and India
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced that its subsidiary Shanghai...
LG Chem’s Cross-Linked Sodium Hyaluronate Gel Gains NMPA Approval for Midface Use
South Korea’s LG Chem announced that its cross-linked sodium hyaluronate gel with lidocaine has received...
Eli Lilly’s Amyvid Sees FDA-Approved Label Update for Alzheimer’s Diagnosis
US-based Eli Lilly & Co. (NYSE: LLY) announced the US Food and Drug Administration (FDA)...
Acotec Scientific Wins NMPA Approval for Armoni-HP Balloon Catheter
China-based Acotec Scientific Holdings Ltd (HKG: 6669) announced that it has received marketing approval from...
GE Healthcare Wins FDA Approval for Vizamyl Label Update in Alzheimer’s Detection
US medical device and life sciences giant GE Healthcare Technologies Inc., (NASDAQ: GEHC) announced that...
Lundbeck’s Lu AG13909 Wins Orphan Drug Designations for Congenital Adrenal Hyperplasia
Denmark-based pharmaceutical company Lundbeck A/S (OTCMKTS: HLUBF) announced that it has received Orphan Drug Designations...
Dynamiker Bio’s Aspergillus Detection Kit Wins NMPA Marketing Approval
China-based Dynamiker Biotechnology (Tianjin) Co., Ltd. announced that it has received marketing approval from the...
GSK Gains FDA Clearance for Benlysta Autoinjector in Pediatric Lupus Nephritis
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received clearance from the US Food...
FDA Approves AstraZeneca’s Datopotamab deruxtecan for EGFR-Mutated NSCLC
The US Food and Drug Administration (FDA) this week approved Datopotamab deruxtecan (Dato-DXd), a TROP-2-targeted...
Merck’s Prevymis Approved in China for Pediatric CMV Prevention
US-based pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that its novel non-nucleoside...
Sansure Biotech Wins NMPA Approval for Fungal Infection Detection Kit
China’s National Medical Products Administration (NMPA) has approved Sansure Biotech Inc.’s (SHA: 688289) Pneumocystis jirovecii,...