Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell ...

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) ...

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 ...

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...

New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...

The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...