Executive Intelligence
Life Sciences Reports
Regulatory, funding, leadership, market and commercial updates selected for life-science executives.
Filters should be used during the administration of Parenteral Nutrition for patients in all care settings DSI/2026/011
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.
Read full reportGuidance: Influenza (Flu) vaccine factsheet – Information for patients, parents and carers
Patient factsheet providing information on influenza (flu) and flu vaccination.
Read full reportVoluntary data submission pilot to advance innovative alternatives to animal testing
EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). These innovative methods have…
Read full reportMHRA regulatory reform amendments tabled in Government’s Health Bill
Proposed amendments to support information sharing, regulatory reform and the future development of a medical device licensing regime.
Read full reportMHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance
Avacopan Vifor is used in the treatment of some rare autoimmune diseases affecting small blood vessels.
Read full reportFDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells.
Read full reportFDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
Read full reportFDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle
FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.
Read full reportCari-Anne Quinn: Turning possibility into progress – health innovation in Wales
Wales’ connected health and life sciences ecosystem creates opportunities to support innovation from development through to adoption, helping new products reach patients while supporting investment and growth.
Read full reportOpportunities for patients and the public to be involved in the work of the MHRA
How we engage and involve patients and the public in our regulatory decision-making.
Read full reportFDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.
Read full reportIncreased risk of wear and corrosion identified with certain cobalt chrome modular neck hip replacements
While most patients implanted with these hip replacements have well-functioning hips and are unlikely to develop serious problems, a small number may develop issues.
Read full reportCobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of revision surgery due to adverse local tissue reaction (ALTR).
Read full reportMedicines: apply for a parallel import licence
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Read full reportFDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.
Read full reportMHRA Safety Roundup: August 2026
Summary of the latest safety advice for medicines and medical device users
Read full reportStandard: Category lists following implementation of the Windsor Framework
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Read full reportNGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
The NGPod handheld device and NGPod sensor, used to test pH to aid the placement of nasogastric tubes, is being withdrawn from the UK market. The manufacturer has ceased trading in the UK. Users should quarantine all remaining stock and dispose of…
Read full reportField Safety Notices: 17 to 21 August 2026
List of Field Safety Notices from 17 to 21 August 2026.
Read full reportGuidance: Guidance on pharmacovigilance procedures
This guidance summarises our approach to pharmacovigilance
Read full reportClass 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles.
Read full reportClass 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles.
Read full reportFDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa)
Read full reportFDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device
The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention.
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