Executive Intelligence
Life Sciences Reports
Regulatory, funding, leadership, market and commercial updates selected for life-science executives.
FDA Launches New Program to Advance Neuroscience Medical Product Development
FDA announces the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program aligned with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments.
Read full reportGovernment confirms indefinite recognition of CE marked medical devices
Patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.
Read full reportMedical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
This consultation invites views on proposals for recognising CE marked medical devices in Great Britain.
Read full reportFDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
FDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.
Read full reportFDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
Today, the U.S. Food and Drug Administration approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week.
Read full reportFDA Issues Final Guidance on Prescription Drug Apps and Software
The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines.
Read full reportIXCHIQ Chikungunya vaccine: UK marketing authorisation withdrawn following safety review
Following advice from the Commission on Human Medicines (CHM), the MHRA has concluded that the benefit-risk balance for the IXCHIQ chikungunya vaccine is no longer considered favourable and the UK marketing authorisation has been withdrawn.
Read full reportFDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally advanced rectal cancer to avoid common treatments that can have a lasting impact on their daily…
Read full reportMHRA authorises plozasiran (Redemplo) for adults with familial chylomicronaemia syndrome
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 October 2026, authorised plozasiran (Redemplo)
Read full reportUK regulator brings new AI and MedTech agenda to AdvaMed
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) sets out its next phase of MedTech and AI regulation to US industry leaders at AdvaMed 2026.
Read full reportField Safety Notices: 5 to 9 October 2026
List of Field Safety Notices from 5 to 9 October 2026.
Read full reportField Safety Notices: 12 to 16 October 2026
List of Field Safety Notices from 12 to 16 October 2026.
Read full reportConsultation on schools holding Adrenaline Nasal Sprays for anaphylaxis
The MHRA are seeking feedback on proposals to amend the Human Medicines Regulations 2012 to allow schools to hold Adrenaline Nasal Sprays to treat anaphylaxis in pupils.
Read full reportMHRA consults on proposals to allow schools to keep spare adrenaline nasal sprays on site
The MHRA is now consulting on proposals that would give schools an additional option to support children at risk of life-threatening allergic reactions.
Read full reportField Safety Notices: 27 to 31 January 2025
List of Field Safety Notices from 27 to 31 January 2025.
Read full reportMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026
Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.Rasonque (daraxonrasib)…, CHMP statistics Key figures from the October 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive…
Read full reportCounterfeit weight loss pens worth £2 million seized by MHRA and West Midlands Police
Fake weight loss medicines worth approximately £2 million were seized last night in a raid executed by the Medicines and Healthcare products Regulatory Agency (MHRA) and West Midlands Police.
Read full reportEMA recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Rasonque (daraxonrasib), an oral treatment for adults with…
Read full reportMHRA introduces new safeguards to strengthen antidepressant safety information following major review
New and updated patient information for antidepressant medicines to be introduced following an extensive review involving patients, families and independent experts.
Read full reportAntidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction
New safety measures are now being implemented to improve how the risks of suicidal thoughts and behaviours and persistent sexual dysfunction are communicated to patients taking antidepressant medications.
Read full reportResearch: Antidepressants – updated safety communications
Public Assessment Report on the review of antidepressants. How the risks of suicidal thoughts and behaviours and sexual dysfunction (where symptoms continue after stopping treatment), are communicated to patients.
Read full reportGuidance: Antidepressants: use and safety
Guidance on the use and side effects of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs), their safety, use in pregnancy and the risk of suicidal behaviour.
Read full reportFDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.
Read full reportFDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
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