The draft MHRA guidance aims to clarify and streamline pathways for bringing these therapies through to patients, without ...

New guidance helps manufacturers navigate medical device regulations and protect users of digital mental health technologies. The Medicines and ...

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

Similarly, the UK’s MHRA has said they want to increase the use of digital twins, and the EU also published a paper on the use of AI in clinical trials. Further demonstrating the evolving nature ...

But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings. Astonishingly, I was actually threatened ...

Gilead Sciences’ Livdelzi (seladelpar) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with the rare liver disease primary biliary cholangitis (PBC) ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) isn't sufficiently funded to meet its obligations, according to a new report commissioned by a pharma trade organisation.

The U.K. Medicines and Health Care Products Regulatory Agency has provided guidance on what does and does not constitute a regulated digital mental health technology, but developers should be aware ...

Concluding his report, Mr Fleming asked the DfT and the Medicines & Healthcare Products Regulatory Agency (MHRA) "to review the adequacy of the existing guidelines and regulations and to consider ...

During late 2024, the MHRA – as part of a broader consultation on routes to market – restated its intention for the future UK regulation of medical devices to rely on the work of four other ...

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback from industry stakeholders ... In the European Union (EU), there are currently no regulatory guidelines specifically ...

Credit: MacroEcon/Shutterstock. Entrada Therapeutics has secured authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin the randomised, two-part Phase I/II ...