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Food and Drug Administration

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Carthera receives EMA endorsement for orphan medical device status of SonoCloud

July 2, 2025
Medical 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 …

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researchers

Moleculin secures EMA approval to expand acute myeloid leukaemia trial across EU

May 16, 2025
Research 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 …

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The Food and Drug Administration (FDA)

October 1, 2010
FDA, 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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The Gateway to Local Adoption Series

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STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases

December 18, 2025

Norgine enters exclusive licensing agreement with Vir Biotechnology

December 18, 2025

Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025