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...
Product approvals
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,...
Broncus Medical Wins NMPA Approval for BroncAblate RFA System Console
Shanghai and Hangzhou (China), and San Jose and Seattle (United States)-based Broncus Medical (HKG: 2216)...
EMA Panel Recommends Bio-Thera’s Usymro for Autoimmune Diseases
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
J&J’s Darzalex SC Recommended by CHMP for High-Risk Smoldering Multiple Myeloma
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
Simcere Pharma’s Quviviq Receives NMPA Approval for Insomnia Treatment
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) revealed that its marketing approval filing for Quviviq...
Sanofi and Regeneron Win FDA Approval for Dupixent in Bullous Pemphigoid Treatment
France major Sanofi (NASDAQ: SNY) and US-based biopharma Regeneron (NASDAQ: REGN) announced that Dupixent (dupilumab)...
Zai Lab’s Partner argenx Secures EU Approval for Vygart in CIDP Treatment
China-based Zai Lab Limited’s (NASDAQ: ZLAB, HKG: 9688) Dutch partner argenx SE (NASDAQ: ARGX) announced...