Takeda’s Takhzyro Receives EMA Approval for New Administration Form in HAE Patients
Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved...
Product approvals
Meyer FSMP Hong Kong Secures NMPA Approval for First FSMP in Greater China
Hong Kong-based Meyer FSMP Hong Kong Limited, an oncology-focused foods for special medical purpose (FSMP)...
Subtle Medical Integrates DeepSeek with FDA-Approved SupMR AI Platform
Shanghai-based Subtle Medical Inc., an AI-powered medical imaging firm operating in the U.S. and China,...
MicroPort CardioFlow’s AnchorMan LAA Occluder System Earns CE Mark Approval
Hong Kong-listed MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has received the CE mark for...
Roche’s Tecentriq Wins Japan Approval for Alveolar Soft Part Sarcoma
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) and its Japanese partner Chugai Pharmaceutical Co.,...
Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the...
Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai,...
Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products...
Huadong Medicine’s MediBeacon TGFR System Approved by NMPA for GFR Measurement
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received marketing approval from...
Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received...
Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the...
Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar...
GSK’s Penmenvy Meningococcal Vaccine Approved by FDA for Ages 10-25
UK-based multinational GSK plc (LON: GSK) announced that it has received marketing approval from the...
LINDIS Biotech’s Korjuny Approved by European Commission for Malignant Ascites
Germany-based LINDIS Biotech GmbH announced that it has received market approval from the European Commission...
SciClone’s Vibativ Approved by NMPA for HABP/VABP Treatment
China-based SciClone Pharmaceuticals Inc. announced that it has received market approval from the National Medical...
Merck’s Zerbaxa Approved by China’s NMPA for Complex Infections
US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has...
Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy
Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the...
Pfizer’s Adcetris Gets New FDA Approval for Lymphoma Treatment
US giant Pfizer (NYSE: PFE) has announced that it has received another indication approval from...
Astellas Pharma’s Izervay Gets FDA Approval for GA Treatment Without Dosing Limit
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration...
Bayer’s Acoramidis (Beyonttra) Gets EMA Marketing Approval for ATTR-CM Treatment in EU
Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for...