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 ...
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 ...
Pharmabiz3h
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] ...
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) ...
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 ...
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.
stocknews12h
3 Precision Medicine Stocks That Could Transform Healthcare
With the robust demand for personalized medicines and the growing adoption of digital technology, the precision medicine ...
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 ...
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 ...
pharmaphorum3d
EMA’s strategy for speeding up drug approvals in the EU
The European Medicines Agency (EMA) has experienced a turbulent few years. Brexit left the agency reeling, as it was forced to move from its base in London and reduce its services whilst ...