Executive Intelligence
Life Sciences Reports
Regulatory, funding, leadership, market and commercial updates selected for life-science executives.
Guidance: The Centres of Excellence for Regulatory Science and Innovation programme (CERSIs)
A national programme to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
Read full reportField Safety Notices: 21 to 25 September 2026
List of Field Safety Notices from 21 to 25 September 2026.
Read full reportField Safety Notices: 21 to 25 September 2026
List of Field Safety Notices from 21 to 25 September 2026.
Read full reportMHRA Safety Roundup: September 2026
Summary of the latest safety advice for medicines and medical device users
Read full reportMHRA Safety Roundup: September 2026
Summary of the latest safety advice for medicines and medical device users
Read full reportMHRA Safety Roundup: September 2026
Summary of the latest safety advice for medicines and medical device users
Read full reportFDA Approves First Treatment for MCT8 Deficiency
The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on metabolism) in…
Read full reportFDA intends to evaluate changes to the PMTA regulatory framework
FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework.
Read full reportProfessor Dame Anna Dominiczak, Professor Alison Strath, and Fiona Cohrane: Catalysing the medicines ecosystem in Scotland
Scotland’s growing commercial research infrastructure and strong NHS, academic and industry partnerships are helping widen access to clinical trials, accelerate adoption and strengthen the UK life sciences ecosystem.
Read full reportFive new commissioners appointed to the Commission on Human Medicines (CHM)
The CHM provides independent expert advice to ministers on the safety, quality and efficacy of medicines.
Read full reportMHRA welcomes sentencing after fraud convictions over falsely certified medical devices
Following convictions related to falsely certified medical devices, the MHRA has welcomed the sentencing in a long-running enforcement investigation.
Read full reportFederal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
Read full reportMHRA approves lurbinectedin for adults with extensive-stage small cell lung cancer
As with all licensed medicines, the MHRA will keep the safety and effectiveness of lurbinectedin under close review.
Read full reportClass 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion, EL(26)A/39
B. Braun Melsungen AG has notified the MHRA that errors have been identified in the Patient Information Leaflet (PIL) included in some batches of Meropenem 1000 mg powder and solvent for solution for infusion.
Read full reportField Safety Notices: 14 to 18 September 2026
List of Field Safety Notices from 14 to 18 September 2026.
Read full reportClinical trials for medicines: Good clinical practice inspections
Information relating to good clinical practice (GCP) inspections.
Read full reportBeyond ADMET: AI for medicines safety – survey
The MHRA and the Regulatory Innovation Office (RIO) invite organisations to share their views on the use of artificial intelligence (AI) in medicines development.
Read full reportFunding opportunity launched to strengthen UK regulatory science and support healthcare innovation
Four new centres of excellence will bring together expertise across academia, industry, healthcare and regulation to keep pace with advances in healthcare and life sciences
Read full reportFDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
The FDA today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.
Read full reportMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026
12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting.The committee recommended…, CHMP statistics Key figures from the September 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency, CHMP statistics:…,…
Read full reportFDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A.
Read full reportRadiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)
The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices.
Read full reportClass 4 Medicines Defect Notification: Martindale Pharmaceuticals Ltd, Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml, EL(26)A/38
Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.
Read full reportPre-submission Advice & Support for Innovative Medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations and clinical variations innovative medicines.
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