Regulatory news | BioWorld

April 7, 2020
By Tamra Sami
FDA accepts Mesoblast’s BLA for pediatric GVHD stem cell therapy under priority review
PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
April 7, 2020
By Tamra Sami
Australia’s Genetic Signatures garners CE mark for its Easyscreen PCR COVID-19 diagnostic
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.
April 7, 2020
Regulatory front for April 7, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Biotechnology Innovation Organization, Central Drugs Laboratory, Drugs Controller General, EMA, FDA, Gilead Sciences, Health and Human Services, Medicines and Healthcare Products Regulatory Agency, National Institute for Health and Care Excellence, Pfizer Healthcare India, Pharmaceuticals and Medical Devices Agency.

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