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Medicines and Healthcare products Regulatory Agency

812 articles

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MHRA guidance on new Medical Devices Post Market Surveillance requirements

MHRA guidance on new Medical Devices Post Market Surveillance requirements

Wednesday, 15 January 2025

A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). ...

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New MHRA Chair Anthony Harnden outlines priorities as he starts role

New MHRA Chair Anthony Harnden outlines priorities as he starts role

Thursday, 02 January 2025

Professor Anthony Harnden has officially started his role as Chair of the Medicines and Healthcare products Regulatory Agency (MHRA)....

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Sotatercept approved to treat adult patients with pulmonary arterial hypertension (PAH)

Sotatercept approved to treat adult patients with pulmonary arterial hypertension (PAH)

Tuesday, 31 December 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved (27 December 2024) the medicine sotatercept (Winrevair) to treat pulmonar...

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Tarlatamab approved to treat adult patients with small cell lung cancer 

Tarlatamab approved to treat adult patients with small cell lung cancer 

Tuesday, 31 December 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 31 December 2024, approved the medicine tarlatamab (Imdylltra) to treat adul...

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UK medicines regulator warns against buying weight loss medicines without a prescription this New Year

UK medicines regulator warns against buying weight loss medicines without a prescription this New Year

Monday, 30 December 2024

The MHRA’s Criminal Enforcement Unit works to identify and prevent the illegal sale of weight-loss medicines online....

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Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy (DMD)

Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy (DMD)

Friday, 20 December 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (20 December 2024) granted a conditional marketing authorisation for the medi...

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Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today

Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today

Thursday, 12 December 2024

The amended regulatory framework will speed up trial approvals and encourage innovation in trial design without compromising patient safety...

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Medicines and medical devices: Six tips for staying healthy and safe this festive season 

Medicines and medical devices: Six tips for staying healthy and safe this festive season 

Wednesday, 11 December 2024

From coughs and sneezes to mental health apps, these tips from the MHRA will help you stay safe during the festive season and beyond...

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Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema

Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema

Tuesday, 10 December 2024

The Medicines and Healthcare products Regulatory Agency has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand ecze...

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MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach

MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach

Wednesday, 04 December 2024

The pilot scheme, AI Airlock, is designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, saf...

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The MHRA issues final call to comply with Windsor Framework arrangements for medicines from January 2025

The MHRA issues final call to comply with Windsor Framework arrangements for medicines from January 2025

Friday, 29 November 2024

With industry already showing a very high level of readiness, the MHRA is reminding remaining marketing authorisation holders to ensure they are prepa...

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MHRA approves new diagnostic agent for adult patients showing signs of cognitive impairment for Alzheimer’s disease

MHRA approves new diagnostic agent for adult patients showing signs of cognitive impairment for Alzheimer’s disease

Wednesday, 27 November 2024

The Medicines and Healthcare products Regulatory Agency has approved the medicine flortaucipir (Tauvid), given to adults with memory problems so that ...

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Sparsentan approved to treat adult patients with primary immunoglobulin A nephropathy (IgAN)

Sparsentan approved to treat adult patients with primary immunoglobulin A nephropathy (IgAN)

Monday, 18 November 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sparsentan (Filspari) to treat primary immunoglobulin A nephr...

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MHRA approves adapted Nuvaxovid JN.1 COVID 19 vaccine for adults and children aged 12 plus

MHRA approves adapted Nuvaxovid JN.1 COVID 19 vaccine for adults and children aged 12 plus

Friday, 15 November 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted version of the Nuvaxovid COVID-19 vaccine that targets the Omic...

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The MHRA seeks views on pre market regulations for medical devices to improve patient access and strengthen patient safety

The MHRA seeks views on pre market regulations for medical devices to improve patient access and strengthen patient safety

Thursday, 14 November 2024

Responses will help shape reforms that will boost UK patients’ access to safe and innovative medical products...

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MedSafetyWeek 2024: Preventing side effects 

MedSafetyWeek 2024: Preventing side effects 

Tuesday, 05 November 2024

The ninth annual #MedSafetyWeek takes place this week, with regulators from 94 countries and 107 organisations taking part across the globe.  ...

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Sugemalimab approved to treat adult patients with non small cell lung cancer???? 

Sugemalimab approved to treat adult patients with non small cell lung cancer???? 

Wednesday, 30 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 30 October, approved the medicine sugemalimab (Eqjubi) to treat adult patien...

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MHRA reminds healthcare professionals to advise patients of the side effects of GLP 1 agonists and to report misuse

MHRA reminds healthcare professionals to advise patients of the side effects of GLP 1 agonists and to report misuse

Wednesday, 23 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding healthcare professionals to ensure patients are aware of the known side ef...

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World Polio Day: MHRA trains worldwide laboratories in early detection of polio using breakthrough advanced technology

World Polio Day: MHRA trains worldwide laboratories in early detection of polio using breakthrough advanced technology

Wednesday, 23 October 2024

Medicines and Healthcare products Regulatory Agency (MHRA) is highlighting our work training multiple World Health Organisation (WHO) polio laboratori...

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Donanemab licensed for early stages of Alzheimer’s disease in adult patients who have one or no copies of apolipoprotein E4 gene

Donanemab licensed for early stages of Alzheimer’s disease in adult patients who have one or no copies of apolipoprotein E4 gene

Tuesday, 22 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 23 October 2024, approved a licence for the medicine donanemab (Kisunla) for...

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Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety

Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety

Tuesday, 22 October 2024

The new legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and pro...

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Statutory Instrument laid in Parliament provides first regulatory framework of its kind that will transform the manufacture of innovative medicines at the point of patient care

Statutory Instrument laid in Parliament provides first regulatory framework of its kind that will transform the manufacture of innovative medicines at the point of patient care

Sunday, 20 October 2024

The UK will be the first country in the world to introduce a tailored framework for the regulation of innovative products manufactured at or close to ...

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Elafibranor approved to treat adults with a rare liver disease known as primary biliary cholangitis

Elafibranor approved to treat adults with a rare liver disease known as primary biliary cholangitis

Wednesday, 16 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved elafibranor (Iqirvo) to treat adult patients with a rare type of liver dis...

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MHRA approves Comirnaty KP.2 COVID 19 vaccine for adults

MHRA approves Comirnaty KP.2 COVID 19 vaccine for adults

Wednesday, 09 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 10 October, approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty)...

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MHRA asks patients to report without delay any safety problem with their continuous glucose monitor or insulin pump

MHRA asks patients to report without delay any safety problem with their continuous glucose monitor or insulin pump

Wednesday, 09 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) is asking patients who use a continuous glucose monitor (CGM) or insulin pump to report...

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MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking new technology while optimising delivery for all who need our services  

MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking new technology while optimising delivery for all who need our services  

Monday, 07 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched its ambitious new business plan for 2024/25, setting out the agency’...

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MHRA approves first medicine for rare immune disease APDS

MHRA approves first medicine for rare immune disease APDS

Friday, 27 September 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has on 25 September approved leniolisib phosphate (Joenja) to treat a rare immune dise...

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MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox

MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox

Sunday, 22 September 2024

The MHRA, is calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulat...

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Fruquintinib approved to treat adult patients with metastatic colorectal cancer ??

Fruquintinib approved to treat adult patients with metastatic colorectal cancer ??

Friday, 20 September 2024

?The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 September, approved the new medicine fruquintinib (Fruzaqla) to treat ad...

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Application route for performance studies under the In Vitro Diagnostics Regulations in Northern Ireland.

Application route for performance studies under the In Vitro Diagnostics Regulations in Northern Ireland.

Thursday, 19 September 2024

Submission and approval enabled of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland due to recent implement...

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