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.

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 ...

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 ...

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 ...

Medical and Healthcare Products Regulatory Agency (MHRA) has released new guidance to help manufacturers meet UK medical ...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced sweeping changes to regulations governing clinical trials, which it says are the largest in more than 20 years.

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...

Following worries that certain patients, including those with eating disorders or a healthy BMI, have been able to receive weight-loss injections like Wegovy and Mounjaro improperly, online pharmacies ...