Guidance on labelling for medicinal products used in clinical trials.
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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.
MHRA approves teplizumab to delay progression of type 1 diabetes
As with any medicine, the MHRA will keep the safety and effectiveness of teplizumab under close review.
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.
Isotretinoin prescribing requirements updated with revised risk-minimisation measures
The updated safety measures will strengthen the MHRA’s ability to monitor safe prescribing while supporting patient access to treatment across all age groups.
Patients will receive medicines 3-6 months faster under 10-Year Health Plan, as regulators set out plans
Under a joint information sharing agreement, pharmaceutical companies will be invited to register early with the MHRA and NICE to allow parallel decision making over licencing and value.