Developers work with the NHS, the medicines regulator and the UK health technology assessment bodies from the early stages of clinical development, as part of the Innovative Licensing and Access Pathway.
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MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components.
Hepatitis B vaccines for babies
All babies in the UK get the hepatitis B vaccine. It has a well-established safety record and ensures long-term protection against the virus.
Public advised to stop using some non-sterile alcohol-free wipes
UKHSA and MHRA are urging the public not to use 4 specified non-sterile alcohol-free wipe products due to the risk of infection associated with their use.
Medicines and Medical Devices Act 2021 – Stakeholder survey
We invite feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021.
AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
MHRA opens second round of applications to test cutting-edge AI medical technologies following successful pilot phase.