for which we have obtained FDA and European Medicines Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing ...
Gilead Sciences (GILD) said on Friday that the European Commission (EC) granted conditional marketing authorization for ...
Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar ...
Biliary tract cancer is increasing in incidence and mortality across Europe, with more people under the age of 60 years old ...
The evolution of cell and gene therapy is reshaping drug discovery, providing new hope for rare diseases and cancer through innovative gene editing approaches.
Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell ...
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
Tampere University has licensed a drug molecule intended for treating Epidermolysis Bullosa (EB), a group of rare and severe skin disorders, to Theravia, a pharmaceutical company headquartered in the ...
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 ...
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...