The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regul
The UK drugs regulator has approved Eisai and Biogen's Alzheimer's disease therapy Leqembi, shortly after an EU committee turned it down on the grounds that its modest efficacy did not outw
The UK’s MHRA recently published its guidance on its approach to both regulating the use of AI for drug and medical devices, and how it can utilise the technology to improve its regulating
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said it will launch a pilot programme in the coming weeks to see how it can evolve the regulation o
Neurogene has reported encouraging efficacy results with its gene therapy for rare genetic disorder Rett syndrome, but investors' concerns about safety seem to be weighing on its share pric
Investigator sites are essential for successful execution of clinical trials – ensuring studies are conducted ethically, safely, and in compliance with regulatory standards.