Executive Intelligence
Life Sciences Reports
Regulatory, funding, leadership, market and commercial updates selected for life-science executives.
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of Tuzulby prolonged release 20mg, 30mg and 40mg chewable tablets.
Read full reportFDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
Read full reportFDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.
Read full reportCorporate report: MHRA: policy for handling corporate conflicts of interest
Information about how we handle potential corporate conflicts of interest (COI) between different parts of the Agency.
Read full reportDomperidone: new contraindication in patients with phaeochromocytoma due to the risk of severe hypertension
The product information has been updated for all domperidone products, to include a contraindication for patients with confirmed or suspected phaeochromocytoma (a rare tumour of the adrenal gland), due to the risk of episodes of severe hypertension.
Read full reportMHRA approves world’s first lower-carbon beclometasone inhalers for patients with asthma
The new inhalers use a next-generation propellant designed to reduce environmental impact while maintaining the same established treatment.
Read full reportDecision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Read full reportField Safety Notices: 13 to 17 July 2026
List of Field Safety Notices from 13 to 17 July 2026.
Read full reportClass 4 Medicines Defect Notification: Macarthys Laboratories Ltd T/A Martindale Pharma, Xaggitin XL Prolonged-release Tablets, EL(26)A/35
Macarthys Laboratories Ltd T/A Martindale Pharma has notified the MHRA of a manufacturing issue impacting several batches of Xaggitin XL Prolonged-release Tablets, due to the occurrence of incorrect tablet counts in the bottles.
Read full reportRegister medical devices to place on the market
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Read full reportGuidance: Medical devices: legal requirements for specific medical products
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Read full reportGuidance: Custom-made medical devices in Great Britain
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Read full reportDecision: Medical devices given exceptional use authorisations
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Read full reportDecision: Orphan registered medicinal products
A list of authorised orphan medicinal products registered by the UK licensing authority.
Read full reportGuidance: Medical devices: list of UK approved bodies
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Read full reportFDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemi
Read full reportHot cars, hot luggage: why where you store your medicines matters this summer
As part of the ‘Summer-proof your health’ campaign, the MHRA is reminding people that heat and poor storage, at home or while travelling, can affect how well some medicines work.
Read full reportCorporate report: Human Medicines Regulations (2012) Advisory Bodies Annual Report 2025
Annual Report of the Human Medicines Regulations (2012) Advisory Bodies - the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.
Read full reportGuidance: AI Airlock Sandbox Phase 2 Programme Report
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
Read full reportMeeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026
CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Bexatil for the reduction of hyperglycaemia in cats…
Read full reportMHRA delivers record performance as 2025-26 Annual Report and Accounts confirms growing global influence
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2025–26 Annual Report and Accounts highlighting a year of strong and consistent delivery as set out in the agency’s first Results and Forecast report earlier this year.
Read full reportFDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasis) in horses when administered within 24 hours of birth or at the time of…
Read full reportUpdated warnings for botulinum toxin products following rare cases of botulism
The MHRA is strengthening safety warnings for all botulinum toxin type A products, following reports of rare cases of botulism linked to their use.
Read full reportEMA and EISMEA boost cooperation to accelerate health innovations
EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today…, Enabling innovation is central to our public health mission to bring new treatments to patients. Our…
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