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Industry newsNICE increases access to SGLT-2 inhibitors medicines to help treat type 2 diabetes
This industry news update is on SGLT-2 inhibitors that NICE are expanding access for as an alternative treatment for type 2 diabetes.
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Industry newsSurvey shapes Regulatory Rapporteur’s future plans
An update on how readers’ feedback is informing future developments for Regulatory Rapporteur.
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Industry newsEFPIA publishes guidance document to help support novel methodology submissions
This industry news update shares the EFPIA’s guidance document to help support the submission process for novel methodologies.
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Industry newsNew Director appointed at the FDA’s Center for Drug Evaluation and Research
This industry news update discusses George Francis Tidmarsh, M.D., Ph.D., who has been appointed as Director of the Center for Drug Evaluation and Research.
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Industry newsFDA makes labelling changes to opioid products mandatory
This industry news update shares the FDA’s labelling requirements for opioid products and what changes must be applied.
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Industry newsEMA and ICH call for more real-world evidence in regulatory practices
This industry news update explores the growing need for more real-world evidence and real-world data.
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Industry newsEMA publishes workplan on how to harness data and AI for public health
This industry news update discusses the EMA’s workplan on how to use data and AI to improve public health.
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Industry newsNICE rejects funding for Lecanemab as treatment benefits ‘remain too small’
The National Institute for Health and Care Excellence (NICE) has recently announced that it will not back funding for the Lecanemab due to concerns about its effectiveness.
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Industry newsExtension to ICMRA post-approval change collaborative pilots
This industry news update looks at the collaborative pilots led by the ICMRA and other regulatory agencies.
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Industry newsNHS app opens access to trials for UK patients
This industry news update looks at the NHS app and the opportunities for patients to take part in clinical trials.
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Industry newsUpdated post-market surveillance requirements take effect
This industry news update looks at the MHRA’s new PMS requirements for medical devices that took effect on 16 June 2025.
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Industry newsFDA to replace animal testing with new approach methodologies
The US Food and Drug Administration (FDA) has announced plans to replace animal testing for monoclonal antibodies (MABs).
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Industry newsEMA to address antimicrobial resistance risks from veterinary medicinal products
The European Medicines Agency (EMA) has published a new concept paper outlining plans to assess the risks of humans developing AMR from VMPs via the environment.
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Industry newsMHRA authorises new cancer treatment variation with significantly reduced administration time
On 30 April 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised a new under-the-skin injection variation of nivolumab (OPDIVO). This offers a quicker administration of the treatment for eligible patients.
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Industry newsMHRA provides guidance to streamline safety communication
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on safety communications to ensure that medicines, medical devices and other healthcare products reach ‘high standards of safety, quality and efficacy.’
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Industry newsKey milestone reached in African medicines regulation
A key milestone for medicines regulation in Africa has been reached with the first continental listing of five medicinal products by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee.
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Industry newsRui Santos Ivo elected as new Chair of the EMA Management Board
Rui Santos Ivo has been elected as the new Chair of the European Medicines Agency (EMA) Management Board. Mr Santos Ivo takes over from Lorraine Nolan, who completed her tenure on 21 March 2025.
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Industry newsUK life science sector calls for more diverse workforce skills to secure future growth
To deliver cutting-edge treatments and revolutionise patient outcomes, the future life sciences sector workforce must be equipped with skills ranging from advanced scientific expertise, digital proficiency and AI-driven problem solving, according to a newly published report.
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Industry newsMHRA appoints new Chief Executive Officer
Lawrence Tallon has been appointed the new Chief Executive Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) and will begin the role on 1 April 2025.
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Industry newsMHRA approves Nemolizumab for eczema patients in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.