European Medicines Agency (EMA)
EMA grants orphan drug designation for Roca’s treatment of radiation maculopathy
August 28, 2025Medical 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 …
EMA lifts temporary ban on chikungunya vaccine Ixchiq following safety review
July 18, 2025Medical 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 …
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 …
Thermosome secures FDA Orphan Drug Designation for soft tissue sarcoma therapy
May 12, 2025Research 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, …
