PipelineReview.com13h
Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis
Approved, Seladelpar Can Provide an Important Treatment Option for People Living With the Rare Liver Disease in the European Economic Area – ...
Pharmabiz18h
Sobi & Apellis Pharma announces EMA validates indication extension application for Aspaveli for treatment of C3G and primary IC-MPGN
Stockholm, Sweden Saturday, February 22, 2025, 09:00 Hrs [IST] ...
Gilead’s Seladelpar gets European Marketing Authorization for liver disease treatment
Gilead Sciences (GILD) said on Friday that the European Commission (EC) granted conditional marketing authorization for ...
PMLiVE1d
EC approves Biocon’s Stelara biosimilar Yesintek for inflammatory diseases
The European Commission (EC) has approved Biocon Biologics’ Yesintek, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple inflammatory diseases.
centerforbiosimilars1d
The Top 5 Biosimilar Articles for the Week of February 17
Number 4: The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis ...
European study highlights inequalities in diagnosis and treatment of biliary tract cancer
Biliary tract cancer is increasing in incidence and mortality across Europe, with more people under the age of 60 years old ...
Managed Healthcare Executive2d
FDA, EMA See Differences in Cell and Gene Therapy Trial Data
Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell ...
Apellis and Sobi Announce EMA Validation of Indication Extension Application for Aspaveli® (pegcetacoplan) for C3G and Primary IC-MPGN
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli ® (pegcetacoplan) ...
GEN3d
C3i Center Receives EMA Approval to Manufacture Cell Therapy Products for Europe
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
C3i Center, a Canadian company, receives approval from the EMA to manufacture cell therapy products for the European market
C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies ...