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 ...
Pharmabiz1h
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] ...
Hosted on MSN7d
EU reshapes HTAs: is the industry ready for it?
New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
NL Times7d
Russian spies had access to EMA systems for four months in 2020 hack: report
Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...
DIA Europe 2025 to Address EU Regulatory Reforms and How to Advance Global Healthcare Harmonization
DIA's Europe Annual Meeting, featuring discussions from top European health leaders, will be held March 18-20 in Basel.
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) ...
GEN2d
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 ...
Medscape7d
EMA Launches Review of Finasteride for Suicidal Ideation
The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...
Managed Healthcare Executive1d
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 ...
centerforbiosimilars4d
FDA, EMA Approve Second Pair of Denosumab Biosimilars
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...
EMA validates indication extension application for Aspaveli® for treatment of C3G and primary IC-MPGN
Sobi® and Apellis Pharmaceuticals today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) for the treatment of C3 ...