Approved, Seladelpar Can Provide an Important Treatment Option for People Living With the Rare Liver Disease in the European Economic Area – ...
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ...
Number 4: The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis ...
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' ...
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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.
The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...
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