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European Medicines Agency (EMA)

Showing 4 posts of 4 posts found.

EMA grants orphan drug designation for Roca’s treatment of radiation maculopathy

August 28, 2025
Medical Communications, Research and Development European Medicines Agency (EMA), Oncology, Opthalmology, Roca Therapeutics, maculopathy

The European Medicines Agency (EMA) has granted Orphan Drug Designation to Roca Therapeutics for its lead candidate RCT002, marking the …

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EMA lifts temporary ban on chikungunya vaccine Ixchiq following safety review

July 18, 2025
Medical Communications Committee for Medicinal Products for Human USE, European Medicines Agency (EMA), Ixchiq, Pharmacovigilance Risk Assessment Committee (PRAC), Vaccine, Virology, chikungunya

After completing a safety review of Ixchiq – a vaccine for chikungunya – the European Medicines Agency’s (EMA) safety committee …

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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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Thermosome secures FDA Orphan Drug Designation for soft tissue sarcoma therapy

May 12, 2025
Research and Development European Medicines Agency (EMA), FDA, Oncology, Thermosome

Thermosome has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its lead candidate, THE001, …

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