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 ...
Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...
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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.
GOTHENBURG, SWEDEN / ACCESS Newswire / February 20, 2025 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, 20 ...
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
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 ...
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) ...
Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell and gene therapies and help ensure consistent safety and efficacy ...
Belgian MEP Liesbet Sommen spoke with Euractiv about critical medicines shortages, EU Pharma Package progress, and SANT's evolving role.
The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee ...
Czechia proposes changes that will better define the role of patient organisations when informing patients about therapeutic procedures without violating advertising regulations.
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