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Industry newsEMA launches #HealthNotHype campaign
This industry news update shares the EMA’s new social media campaign to raise awareness for GLP-1 medicines.
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Industry newsNICE reviews health technology assessment to better support patients
This industry news update shares NICE’s plans to review how health technologies are evaluated.
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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Industry newsRegulatory Rapporteur is back in PDF format
News of an exciting new development for Regulatory Rapporteur starting in October 2025.
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Industry newsMHRA cross-agency team outlines emerging considerations for the manufacture of personalised medicines
This industry news update shares the MHRA’s guidance for the manufacture of personalised medicines.
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Industry newsAI Airlock: Growing the future of artificial intelligence technology in healthcare
This industry news update is about the ongoing projects as a part of AI Airlock led by the MHRA.
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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.