EC Approves AbbVie’s Tepkinly for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific...
Product approvals
Sanofi’s Altuviiio Receives Marketing Approval from Japan’s MHLW for Hemophilia A Treatment
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from...
Japan’s MHLW Approves Eisai and BioArctic’s Leqembi for Alzheimer’s Treatment
The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai...
Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses...
Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US...
Acotec Scientific Holdings Receives Japanese Marketing Approval for Peripheral Support Catheter Vericor
Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it...
Sanofi’s Dupixent Secures NMPA Approval for Pruritigo Nodosa Treatment in China
France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval...
Sansure Biotech Secures CE Mark for 60 Molecular Diagnostic Products, Including Procalcitonin Assay Kit
Sansure Biotech Inc., a leading molecular diagnostics specialist based in China (SHA: 688289), has announced...
Novartis’s Aimovig Approved by China’s NMPA for Preventive Migraines Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from...
Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
US-based Organon (NYSE: OGN) has announced that it has received market approval from the National...
GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE:...
EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently...
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
The US Food and Drug Administration (FDA) has granted priority review status to an indication...
Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo...
AbbVie’s Allergan Aesthetics Secures NMPA Approval for Juvéderm VOLUMA with Lidocaine
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing...
MicroPort MedBot’s SkyWalker Robot Approved for Orthopedic Surgery by NMPA
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing...
Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE:...
EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
EMA’s CHMP Recommends Approval of Keytruda as Adjuvant NSCLC Treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Tuodao Medical’s Percutaneous Puncture Surgery Robot NP100 Approved in China
China-based surgical robot developer Tuodao Medical Technology Co., Ltd has received marketing approval for its...