Life Sciences Reports

Executive Intelligence

Life Sciences Reports

Regulatory, funding, leadership, market and commercial updates selected for life-science executives.

RegulatoryMHRA · 1 month ago

Field Safety Notices: 7 September to 11 September 2026

List of Field Safety Notices from 7 September to 11 September 2026.
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RegulatoryMHRA · 1 month ago

Advanced therapy medicinal products: regulation and licensing in UK

How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
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RegulatoryEMA · 1 month ago

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026

CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Cirbloc, for the active immunisation of pigs from…
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RegulatoryMHRA · 1 month ago

Independent Commission led by NHS doctors sets out blueprint to accelerate safe AI adoption in healthcare

New recommendations based on extensive public engagement set out how the NHS could give patients faster access to AI advances with proportionate safeguards to protect patient safety and maintain high levels of trust.
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RegulatoryMHRA · 1 month ago

Independent Commission led by NHS doctors sets out blueprint to accelerate safe AI adoption in healthcare

New recommendations based on extensive public engagement set out how the NHS could give patients faster access to AI advances with proportionate safeguards to protect patient safety and maintain high levels of trust.
Read full report
RegulatoryMHRA · 1 month ago

Independent Commission led by NHS doctors sets out blueprint to accelerate safe AI adoption in healthcare

New recommendations based on extensive public engagement set out how the NHS could give patients faster access to AI advances with proportionate safeguards to protect patient safety and maintain high levels of trust.
Read full report
RegulatoryMHRA · 1 month ago

Independent Commission led by NHS doctors sets out blueprint to accelerate safe AI adoption in healthcare

New recommendations based on extensive public engagement set out how the NHS could give patients faster access to AI advances with proportionate safeguards to protect patient safety and maintain high levels of trust.
Read full report
RegulatoryMHRA · 1 month ago

Research: National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework

Recommendations from the National Commission into the Regulation of AI in Healthcare, which was established to advise government on a future regulatory framework for AI in healthcare.
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RegulatoryMHRA · 1 month ago

Research: National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework

Recommendations from the National Commission into the Regulation of AI in Healthcare, which was established to advise government on a future regulatory framework for AI in healthcare.
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RegulatoryMHRA · 1 month ago

Research: National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework

Recommendations from the National Commission into the Regulation of AI in Healthcare, which was established to advise government on a future regulatory framework for AI in healthcare.
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RegulatoryMHRA · 1 month ago

Field Safety Notices: 31 August to 4 September 2026

List of Field Safety Notices from 31 August to 4 September 2026.
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RegulatoryMHRA · 1 month ago

Decision: Advertising investigations: August 2026

Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.
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RegulatoryFDA · 2 months ago

FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products

The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN)
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RegulatoryFDA · 2 months ago

FDA Grants Accelerated Approval to a New Breast Cancer Treatment

The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
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RegulatoryEMA · 2 months ago

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August – 3 September 2026

Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicinesEMA’s safety committee, PRAC, has started a review of injectable…, Agenda Agenda of the PRAC meeting 31 August - 3 September 2026Draft Reference Number: EMA/PRAC/164465/2026…, PRAC…
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RegulatoryEMA · 2 months ago

New EU supply chain to end Visudyne shortage

A new supply chain for Visudyne (verteporfin) has been put in place in the European Union (EU), marking an important step towards resolving a long-standing shortage of the…, This situation shows the complexity of shortages and how coordination between the European Commission,…
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RegulatoryFDA · 2 months ago

FDA Approves First Drug to Treat Alexander Disease

The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.
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RegulatoryFDA · 2 months ago

FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats

The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar
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RegulatoryMHRA · 2 months ago

Field Safety Notices: 24 to 28 August 2026

List of Field Safety Notices from 24 to 28 August 2026.
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RegulatoryFDA · 2 months ago

FDA Seeks Public Input to Advance Development of Botanical Drug Products

The U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
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RegulatoryMHRA · 2 months ago

Medicines: reclassify your product

Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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RegulatoryMHRA · 2 months ago

Guidance: International Recognition Procedure

How to use the procedure for medicines licensing applications.
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RegulatoryMHRA · 2 months ago

MHRA and Manchester NHS partner on health innovation sandbox

New partnership to create health innovation sandbox that will test promising new technologies and build evidence to accelerate the safe adoption of technologies, including AI, in the NHS.
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RegulatoryMHRA · 2 months ago

Filters should be used during the administration of Parenteral Nutrition for patients in all care settings

Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.
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