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BioWorld - Monday, January 12, 2026
Home » Topics » Regulatory

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Stem cells

FDA accepts Mesoblast’s BLA for pediatric GVHD stem cell therapy under priority review

April 8, 2020
By Tamra Sami
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).
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Regulatory front for April 8, 2020

April 8, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: General Motors, Inbios International, Philips, Ventec Life Systems.
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Regulatory actions for April 8, 2020

April 8, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Aeglea, Aeterna Zentaris, Algernon, Bellerophon, BMS, Nicox, Polaryx and Roche.
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Regulatory front for April 8, 2020

April 8, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Bausch Health, Mylan, Valeant.
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FDA accepts Mesoblast’s BLA for pediatric GVHD stem cell therapy under priority review

April 7, 2020
By Tamra Sami
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).
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4-7-Genetic-Signature-Easyscreen.png

Australia’s Genetic Signatures garners CE mark for its Easyscreen PCR COVID-19 diagnostic

April 7, 2020
By Tamra Sami
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.
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Architectural pillars

Regulatory front for April 7, 2020

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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Regulatory actions for April 7, 2020

April 7, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cochlear, Genetron, Gnomegen, Motus GI, Nitiloop, Orthosensor.
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Regulatory front for April 7, 2020

April 7, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3M, Boston Scientific, Gnomogen, Viracor Eurofins Clinical Diagnostics.
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Regulatory actions for April 7, 2020

April 7, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Alnylam, Ascentage, Blaze, Immunomedics, Merck.
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