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Medicines and Healthcare products Regulatory Agency

782 articles

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Marstacimab approved to treat patients aged 12 years and above (weighing at least 35 kg) with haemophilia A or B

Marstacimab approved to treat patients aged 12 years and above (weighing at least 35 kg) with haemophilia A or B

Tuesday, 22 April 2025

As with all products, the MHRA will keep its safety under close review....

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Patients urged to check packs of blood pressure medicine lercanidipine after labelling error

Patients urged to check packs of blood pressure medicine lercanidipine after labelling error

Thursday, 17 April 2025

Patients who take the common blood pressure medicine Lercanidipine HCI 20mg tablets (lercanidipine hydrochloride) from the manufacturer Recordati Phar...

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Clinical Trials regulations signed into law

Clinical Trials regulations signed into law

Thursday, 10 April 2025

12-month roll-out begins today for the biggest regulatory shake up of clinical trials in 20 years...

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First ever MHRA analysis of UK clinical trial applications finds new opportunities to drive medical breakthroughs for patients

First ever MHRA analysis of UK clinical trial applications finds new opportunities to drive medical breakthroughs for patients

Thursday, 10 April 2025

New analysis of the current clinical trial landscape in the UK shows clear opportunities to shape the future of medical research and patient care....

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World Health Organization confirms MHRA to continue playing vital role in ensuring the quality of global biological medicines? 

World Health Organization confirms MHRA to continue playing vital role in ensuring the quality of global biological medicines? 

Wednesday, 09 April 2025

The World Health Organization (WHO) has confirmed the successful redesignation of the Medicines and Healthcare products Regulatory Agency (MHRA)’s Sci...

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Trastuzumab deruxtecan approved to treat adults with HER2 positive cancer that has spread or cannot be removed by surgery 

Trastuzumab deruxtecan approved to treat adults with HER2 positive cancer that has spread or cannot be removed by surgery 

Tuesday, 08 April 2025

As with all products, the MHRA will keep its safety under close review....

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Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy

Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy

Friday, 04 April 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with ...

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MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner

MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner

Tuesday, 01 April 2025

Seven new CERSIs came together to showcase how partnerships will modernise regulation in AI, clinical trials, and advanced therapies, bringing innovat...

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Lawrence Tallon begins role as new MHRA CEO

Lawrence Tallon begins role as new MHRA CEO

Tuesday, 01 April 2025

Lawrence Tallon today (1 April 2025) begins his role as Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency (MHRA). ...

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Dame June Raine: How innovations are transforming regulation and speeding new treatments to healthcare

Dame June Raine: How innovations are transforming regulation and speeding new treatments to healthcare

Sunday, 30 March 2025

As Dame June Raine gets ready to pass the baton on after nearly 40 years at the agency, the last five of which she has been CEO, she reflects on how n...

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World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men 

World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men 

Friday, 28 March 2025

As with all products, the MHRA will keep its safety under close review....

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MHRA launches new monthly safety bulletin and redesigned safety alerts

MHRA launches new monthly safety bulletin and redesigned safety alerts

Tuesday, 25 March 2025

The new MHRA Safety Roundup provides a monthly summary of the latest safety advice for all medicines, medical devices, and healthcare products regulat...

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Minister visits MHRA to see cutting edge science protecting patients and supporting the NHS

Minister visits MHRA to see cutting edge science protecting patients and supporting the NHS

Friday, 14 March 2025

The MHRA welcomed Health Minister Smyth to its science campus as part of British Science Week to demonstrate how innovations become safe, effective tr...

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New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infections

New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infections

Friday, 07 March 2025

In a UK-first, the Medicines and Healthcare products Regulatory Agency (MHRA) and Barts Health NHS Trust have developed a DNA sequencing approach that...

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Triple combination medicine deutivacaftor/tezacaftor/vanzacaftor approved for cystic fibrosis

Triple combination medicine deutivacaftor/tezacaftor/vanzacaftor approved for cystic fibrosis

Friday, 07 March 2025

As with all products, the MHRA will keep its safety under close review...

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Lazertinib approved for use in combination with amivantamab for the treatment of adults with non small cell lung cancer 

Lazertinib approved for use in combination with amivantamab for the treatment of adults with non small cell lung cancer 

Thursday, 06 March 2025

As with all products, the MHRA will keep its safety under close review. ...

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Members of the public asked to return Boots Paracetamol 500mg tablets due to packaging error

Members of the public asked to return Boots Paracetamol 500mg tablets due to packaging error

Tuesday, 04 March 2025

People who have purchased Boots Paracetamol 500mg Tablets 16s (Item code 81-99-922, Batch 241005, Expiry date 12/2029) are advised to stop using the p...

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mRESVIA RSV vaccine approved to protect patients aged 60 and over

mRESVIA RSV vaccine approved to protect patients aged 60 and over

Friday, 28 February 2025

A study found that around 4 months after vaccination, people who received the RSV vaccine had a 79% reduction in their risk of getting lower respirato...

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Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK

Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK

Monday, 17 February 2025

This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure....

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Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A

Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A

Friday, 14 February 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 14 February 2025, approved efanesoctocog alfa (brand name Altuvoct) to be us...

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Update on 2 specialist review requirements for male patients already taking valproate  

Update on 2 specialist review requirements for male patients already taking valproate  

Thursday, 13 February 2025

A review by 2 specialists will remain in place for patients starting valproate under 55 years of age....

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Medical imaging agent gozetotide approved for diagnosis of prostate cancer

Medical imaging agent gozetotide approved for diagnosis of prostate cancer

Wednesday, 12 February 2025

Gozetotide binds to the cancer cells with prostate-specific membrane antigen (PSMA) on their surface, making them visible during the PET scan....

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IXCHIQ vaccine approved to protect adults against Chikungunya

IXCHIQ vaccine approved to protect adults against Chikungunya

Tuesday, 04 February 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 4 February 2025, approved the vaccine chikungunya vaccine (live) (brand name...

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MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies  

MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies  

Monday, 03 February 2025

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

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Digital mental health technologies guidance launched to help manufacturers and safeguard users

Digital mental health technologies guidance launched to help manufacturers and safeguard users

Monday, 03 February 2025

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

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UK patients enabled access to transformative new medicines in shortest time possible via new, integrated Innovative Licensing and Access Pathway 

UK patients enabled access to transformative new medicines in shortest time possible via new, integrated Innovative Licensing and Access Pathway 

Thursday, 30 January 2025

It is the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, ...

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Criminals denied £7.5m in profits from the illegal trade in medicines

Criminals denied £7.5m in profits from the illegal trade in medicines

Wednesday, 29 January 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) last year stopped criminals making more than £7.5 million linked to the illegal trade i...

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Garadacimab (andembry) approved to prevent angioedema attacks

Garadacimab (andembry) approved to prevent angioedema attacks

Friday, 24 January 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 24 January 2025, approved garadacimab (brand name Andembry) for patients age...

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Aprocitentan approved to treat adults with hypertension whose blood pressure cannot be controlled by other medications

Aprocitentan approved to treat adults with hypertension whose blood pressure cannot be controlled by other medications

Friday, 17 January 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine aprocitentan (Jeraygo) to treat hypertension (high blood pres...

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Seladelpar approved to treat adult patients in the UK with liver illness

Seladelpar approved to treat adult patients in the UK with liver illness

Thursday, 16 January 2025

As with any medicine, the MHRA will keep the safety and effectiveness of seladelpar under close review.? ...

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