Food and Drug Administration
Carthera receives EMA endorsement for orphan medical device status of SonoCloud
July 2, 2025Medical Communications, Research and Development Brain disorders, Breakthough Device Designation, CE marking, Carthera, Devices, European Medicines Agency (EMA), Food and Drug Administration, Forfait Innovation Status, Neurology, Orphan Medical Device Status, ultrasound imaging
French biotech company Carthera has announced that its SonoCloud system has been granted orphan medical device status by the European …
Moleculin secures EMA approval to expand acute myeloid leukaemia trial across EU
May 16, 2025Research and Development Clinical Trial Application (CTA), European Union (EU), FDA, Food and Drug Administration, Moleculin Biotech, Oncology, Orphan Drug Designation (ODD), acute myeloid leukaemia
Moleculin Biotech has received approval from the European Medicines Agency (EMA) to expand its phase 3 ‘MIRACLE’ trial into nine …
The Food and Drug Administration (FDA)
October 1, 2010FDA, Food and Drug Administration
The current incarnation of the Food and Drug Administration (FDA) was established in 1930, but the US regulator’s modern functions …
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