MHRA Guidance & Safety

Precautionary Recall of Sertraline 100mg Batch V2500425 Due to Packaging Error

Amarox Limited is recalling one batch of Sertraline 100mg film-coated tablets (batch V2500425) as a precautionary measure after a patient complaint identified that packs contained Citalopram 40mg blister strips instead. Both SSRIs are produced at the same site; the error occurred during secondary packaging. Healthcare professionals are advised to stop supplying the affected batch, contact any patients dispensed the product, and report suspected adverse reactions via the MHRA Yellow Card scheme. Patients who believe they have taken the wrong medication are advised to seek medical advice immediately.

UK Clinical Trial Reforms Effective 28 April 2026, Faster Approvals

The MHRA and Health Research Authority are implementing the largest package of clinical trial reforms in over 20 years, effective 28 April 2026. The reforms introduce notifiable trials as a fast-track route for lower-risk studies and legally mandate the Route B substantial modification pathway, which was piloted from October 2025 to March 2026 with an average processing time of seven calendar days. The changes have already contributed to reducing clinical trial set-up times from 169 days to 122 days, and for the first time, registration of clinical trials and publication of summary results will be a legal requirement.

Precautionary Recall of Napralief 250mg, 3 Batches, Missing Patient Safety Information

Omega Pharma Limited is recalling three batches of Napralief 250mg Gastro-Resistant Tablets (B51496, B51497, B51102) as a precautionary measure due to important safety and dosage information missing from the patient information leaflet and outer carton. The MHRA has advised healthcare professionals to stop supplying the affected batches and return all remaining stock to suppliers. Patients may continue using the medicine but should follow the correct dosage instructions: two tablets on the first day, followed by one tablet 6–8 hours later, then one tablet every 6–8 hours on subsequent days, for no more than three days.

Napralief 250mg Gastro-Resistant Tablets Class 3 Recall – Missing PIL Text

Omega Pharma Ltd is recalling three specific batches of Napralief 250mg Gastro-Resistant Tablets (B51496, B51497, B51102) distributed between December 2025 and February 2026, due to missing dosage and safety text in Section 2 and Section 3 of the Patient Information Leaflet and on the carton packaging. Pharmacies and wholesalers are required to stop supplying affected batches immediately, quarantine all stock, and return it to suppliers using approved processes. No further patient action is required as this is a precautionary recall at pharmacy and wholesaler level.

Hiprex 1g Class 4 Defect: Braille Error States 1mg Instead of 1g

Doncaster Pharma Limited has notified the MHRA of a Braille embossing error on outer packaging for certain parallel imported batches of Hiprex 1g tablets (methenamine hippurate). The embossed Braille incorrectly states the strength as 1mg rather than 1g, though all printed text correctly shows 1g. Five batches are affected, distributed between October 2025 and March 2026, all expiring April 2028. The MHRA has classified this as a Class 4 defect and is not recalling the affected products as they remain within specification with no quality issues. Healthcare professionals are advised to explain the error to patients who rely solely on Braille when reading medicine cartons.

Five Medical Device Field Safety Notices Published April 13–17

MHRA published five Field Safety Notices (FSNs) covering the period 13–17 April 2026, affecting five distinct medical devices: Biosense Webster's cardiac irreversible electroporation catheter (09 March 2026), Dexcom's G7 iOS CGM App and Dexcom ONE+ iOS CGM App, Getinge's Stericool sterilant agent (April 2026), The Binding Site Group's EXENT Analyser, and Zimmer's Disposable Mixing Bowls. The notices are published by MHRA for information only; recipients are directed to contact the respective manufacturers directly with questions.

Precautionary Recall of Ramipril 10mg Batch GR174091

Crescent Pharma Limited is recalling one batch of Ramipril 10mg capsules (batch GR174091) as a precautionary measure due to a potential manufacturing error which may mean some cartons contain blister strips of a lower dose, specifically Ramipril 5mg. Both product batches were manufactured at the same manufacturing site, and the error appears to have occurred during secondary packaging of the cartons. The MHRA has advised pharmacy and healthcare professionals to stop supplying the impacted batch and return all remaining stock to their suppliers.

Crescent Pharma Ramipril 10mg Capsules Batch GR174091 Class 2 Recall

Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules (Batch GR174091, expiry 10/2026) as a precautionary measure after one sealed carton was found to contain a blister pack of Ramipril 5mg Capsules instead. This Class 2 Patient, Pharmacy and Wholesaler level recall affects all units of Batch GR174091 distributed from 13 May 2025. Healthcare professionals are instructed to stop supplying the affected batch immediately, quarantine remaining stock, and return it to suppliers, while also identifying and contacting patients who received the impacted product.

RSV Vaccine Factsheet for Patients, Parents and Carers

The MHRA has published a new patient factsheet on RSV vaccination providing comprehensive information on respiratory syncytial virus, vaccine eligibility criteria, safety monitoring via the Yellow Card scheme, side effects, and pregnancy considerations. The factsheet covers UK-licensed RSV vaccines assessed for safety, quality, and effectiveness. This publication supports informed decision-making for patients, parents, carers, and healthcare providers but does not create new regulatory obligations.

Field Safety Notices: 6 to 10 April 2026

MHRA published a weekly compilation of 14 Field Safety Notices for the period 6-10 April 2026, covering medical devices from manufacturers including Allurion, Boston Scientific, Edwards Lifesciences, GE HealthCare, Intuitive Surgical, and Medline. Devices include gastric balloon systems, intraocular lenses, tricuspid heart valve delivery systems, CT scanners, robotic surgical systems, and surgical lighting equipment. The agency notes that FSNs are published for information only and advises contacting manufacturers directly with questions.

Olezarsen (Tryngolza) Approved for Familial Chylomicronemia Syndrome

MHRA granted approval to olezarsen (Tryngolza) on 10 April 2026 to Swedish Orphan Biovitrum AB (publ) for treating adults with familial chylomicronemia syndrome (FCS), an inherited condition causing dangerously high triglyceride levels. A clinical study of 66 adults demonstrated that Tryngolza achieved an average 32% triglyceride reduction after 6 months versus a 12% average increase in the placebo group, with benefits sustained and improved after one year. Healthcare providers and patients in the UK now have a new treatment option for this rare, potentially life-threatening condition.

MHRA-NICE Aligned Pathway Accelerates NHS Patient Access to Medicines

The MHRA and NICE have launched an aligned pathway that synchronises regulatory approval with health technology assessment, enabling simultaneous delivery of both decisions. This coordination is expected to reduce the time for new medicines to reach NHS patients by 3-6 months compared to sequential processing. The initiative includes a webinar on the launch of the MHRA-NICE Aligned Pathway and Integrated Scientific Advice services.

UK and US Deepen Regulatory Cooperation on Medical Devices

The MHRA and US FDA announced they are strengthening cooperation on medical device regulation, building on a wider US-UK pharmaceutical partnership that removes tariffs on UK medicines exports. The two regulators will explore mutual recognition mechanisms and options to reduce duplication in approval processes, while maintaining independent decision-making and stringent safety standards. Technical discussions will continue over the coming months to identify opportunities for closer regulatory alignment.

Sevabertinib (Hyrnuo) Approved for Advanced HER2-Positive Lung Cancer

The MHRA has granted marketing authorisation to Bayer PLC on 1 April 2026 for sevabertinib (Hyrnuo), a protein kinase inhibitor indicated for adults with advanced non-small cell lung cancer (NSCLC) harbouring HER2 mutations that has spread or is unresectable. The approval, coordinated under Project Orbis alongside FDA, TGA, Health Canada, HSA Singapore, Swissmedic, ANVISA Brazil, and Israel's Ministry of Health, was based on clinical trial evidence showing positive responses in 71% of previously treated patients, with many responses lasting six months or longer.

Environmental Risk Assessments for Medicines

The MHRA published guidance on environmental risk assessments (ERAs) for medicinal products in the UK, effective 1 April 2026. All marketing authorisation (MA) applications must now include an evaluation of potential environmental risks posed by the medicinal product, assessing the physicochemical and ecotoxicological properties and environmental fate of the active substance. Where environmental risk cannot be excluded, applicants must propose specific measures to limit environmental impact, with precautionary measures included in the Summary of Product Characteristics (SmPC) and patient information leaflet (PIL) as applicable.

MHRA Safety Roundup March 2026: Drug Recalls and Device Alerts

MHRA published its monthly Safety Roundup for March 2026, aggregating Direct Healthcare Professional Communications and Class 2 medicine recalls issued during February-March 2026. The document includes four Class 2 recalls: Bio Products Laboratory Limited recalled one batch of Rabies Human normal Immunoglobulin due to a stability failure causing reduced potency; Mölnlycke Health Care recalled specific batches of Hibiwash 500ml due to microbial contamination detected during routine weekly microbiological monitoring; Crescent Pharma Limited recalled one batch of Ramipril 5mg capsules as a precautionary measure following a manufacturing error where Amlodipine 5mg Tablets were found inside sealed cartons; and Rokshaw Limited recalled Curaleaf Oil (10mg/ml THC, 10mg/ml CBD). Healthcare professionals should review the full document and associated DHPCs to confirm whether affected products are held in their clinical settings.

Clinical Investigations for Medical Devices in Great Britain

The MHRA has published guidance for manufacturers on conducting clinical investigations for medical devices in Great Britain under the Medical Devices Regulations 2002 (SI 2002 No 618). Manufacturers or UK Responsible Persons must provide 60 days' prior written notice to the MHRA via the Integrated Research Application System (IRAS) portal before making devices available for clinical investigation. The guidance details circumstances requiring clinical investigations, including implantable or Class III devices, novel device concepts, modified devices with novel features, devices with untested materials, and devices proposed for new purposes. Submissions may demonstrate compliance with either UKCA/UK MDR or CE/EU MDR requirements.

Clinical Investigations in Northern Ireland for Medical Devices

Manufacturers conducting clinical investigations for medical devices in Northern Ireland must comply with EU Medical Device Regulation (EU MDR) 2017/745 and EU In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746 under the Northern Ireland Protocol, as Northern Ireland continues to align with EU rules. All notifications must be submitted via the Integrated Research Application System (IRAS) portal, with MHRA conducting a review within 45 days (extendable by 20 days to 65 days total) before issuing authorisation or refusal. Where a clinical investigation includes sites in both Great Britain and Northern Ireland, a single application under EU MDR covers all sites.

Clinical Investigations: Investigators' Responsibilities for Medical Devices

MHRA has published guidance on investigators' responsibilities for medical device clinical investigations. The guidance explains what must be included in submissions notifying MHRA of a manufacturer's plans to undertake a clinical investigation, covering the approval process, conduct requirements, device labelling, and required documentation. Clinical investigators planning medical device studies in Great Britain should review this guidance to ensure their submissions meet current MHRA requirements.

Clinical Investigations: Biological Safety Assessments

MHRA has published guidance on biological safety assessments for clinical investigations of medical devices, outlining the information required in submissions to verify compliance with applicable regulations. The guidance applies to all sponsors and clinical investigators planning clinical investigations of medical devices in the UK and specifies MHRA's expectations for biological safety evaluation documentation. Organisations conducting or planning clinical investigations involving medical devices should review these requirements as part of their regulatory submission preparation.

Clinical Investigations for Electrically Powered Devices

The MHRA has published guidance dated 30 March 2026 for manufacturers and sponsors undertaking clinical investigations of electrically powered medical devices. The document explains the additional information that must be provided to MHRA when submitting a clinical investigation notification. This guidance applies to any party seeking to conduct clinical research on powered medical devices in the UK market.

Clinical Trials Quality and Risk Proportionality Guidance

MHRA has published draft guidance on implementing quality by design, risk-based quality management, and proportionate oversight in UK clinical trials of Investigational Medicinal Products (IMPs), accompanied by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. The guidance interprets ICH E6 (R3) and ICH E8 (R1) principles which are adopted by reference into Schedule 1 of the amended Clinical Trials Regulations, with the amendments coming into force on 28 April 2026. MHRA requests feedback via an online survey by 11.59pm on 15 April 2026.

MHRA and HSA Sign MoU on Healthcare Regulatory Innovation

The MHRA and Singapore's Health Sciences Authority (HSA) signed a refreshed Memorandum of Understanding in London last week, reaffirming their commitment to global regulatory collaboration. The Regulatory Innovation Corridor pilot, launched in December 2025, offers companies a route to engage both regulators simultaneously for early, informal joint advice. Through the Access Consortium with Australia, Canada, and Switzerland, almost 40 new active substances have been approved through work-sharing, benefiting from faster median rollout times. The collaboration aims to accelerate patient access to breakthrough innovations including advanced diagnostics, cell and gene therapies, and AI-driven medical technologies.

Class 4 Medicines Defect Notification: Vesomni 6 mg/0.4 mg Tablets - Incorrect Barcode

Quadrant Pharmaceuticals Limited has issued a Class 4 defect notification for six batches of parallel-imported Vesomni 6 mg/0.4 mg modified release tablets (PLPI: 20774/2577) due to an incorrectly printed barcode/GTIN on the carton. The GTIN printed on affected packs (Batch Nos. 4097Y, 4105Y, 4322Y, 5386Y, 7330Y, 7347Y) is that of Solaraze 3% Gel packs containing diclofenac. Product quality of the tablets is not impacted. Affected batches are NOT being recalled. Healthcare professionals should not use these batches in robotic or automated dispensing or stocking systems and should carry out manual dispensing instead. Patients are advised no action is required and they should continue taking their medication as prescribed.

Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17

The MHRA has issued a Class 4 defect notification for specified batches of Sandoz Apixaban 2.5mg and 5mg tablets (PL 04416/1607 and PL 04416/1608) distributed since January 2026. The Patient Information Leaflet (PIL) included in affected batches is missing updated safety information on the newly authorised paediatric indication for children aged 28 days to under 18 years, and updated guidance on administration at least 5 hours after spinal or epidural catheter removal. The tablets themselves are unaffected; the defect involves labelling only. Healthcare professionals are advised to inform patients and carers of the updated dosing information for children and to contact Sandoz Limited or access the Electronic Medicines Compendium for corrected PILs.

MHRA Offers Early Review of Non-Animal Data for Marketing Authorisations

The MHRA announced a new early-review pathway for pharmaceutical developers using New Approach Methodologies (NAMs), offering to assess Module 4 of Marketing Authorisation applications that rely on non-animal data before a formal submission. By the end of 2026, companies can submit Module 4, the Investigator Brochure, and at least one clinical trial final report for a non-binding written opinion on data adequacy, with a fee charged to recover administrative costs. Pharmaceutical companies developing drugs without animal testing now have a clearer regulatory route to obtain early feedback, reducing uncertainty and supporting the transition to NAM-based development.

Mölnlycke Hibiwash Recalled Over Microbial Contamination

Mölnlycke Health Care is recalling three batches of Hibiwash (batch numbers 5156042, 5156043, and 5156093) due to Burkholderia cepacia contamination detected during routine weekly monitoring at the manufacturing facility. The recall impacts approximately 50,000 units of the antimicrobial wash. No reports of patient harm have been received, and the action is precautionary. Healthcare professionals and retailers must stop supplying affected batches and return stock to suppliers; patients should check batch numbers and return impacted product to a pharmacy for safe disposal.

Field Safety Notices for Medical Devices: 16-20 March 2026

MHRA published 10 Field Safety Notices for medical devices covering the period 16-20 March 2026, affecting products from manufacturers including AusDiagnostics, Clinical Innovations, Diagnostic Grifols, Elekta, GE Medical Systems, Immucor, Medtronic, PathoFinder, Spacelabs, and Stryker. The FSNs cover diagnostic tests, foetal vacuum extraction systems, stereotactic surgery systems, MRI equipment, blood typing reagents, catheters, physiologic monitors, and orthopaedic devices. MHRA clarifies this is published for information only and advises that recipients must always act on FSNs received directly from manufacturers.

Meningitis Patient Factsheet and Vaccination Advice

MHRA published a patient factsheet providing an overview of meningitis, a serious infection affecting the protective layers surrounding the brain and spinal cord. The document explains that meningitis is usually caused by bacterial or viral infection and can develop quickly, with babies, young children, teenagers, young adults, and older adults at greater risk. The factsheet covers bacterial and viral types, available NHS vaccines that protect against main bacterial causes, vaccine safety, and meningitis symptoms.

MHRA Modernises Medicine Information Delivery

MHRA announced its 'Improving Patient Information' project on 18 March 2026, aimed at modernising how medicines product information is delivered to patients. The initiative seeks to make medicine information more accessible, trusted, and future-ready. A linked research report (80 pages, 1.82 MB) titled 'The Role of Patient Information Leaflets in Meeting the Information Needs of Patients' accompanies the project. The project reflects MHRA's commitment to fully inclusive approaches to medicines information for all patients.

Class 4 Defect: Baxter Onkotrone PIL Missing Contraception Duration Update

MHRA has issued a Class 4 Medicines Defect Notification for Baxter Healthcare Corporation's Onkotrone Injection 2mg/ml concentrate for solution for infusion in 10ml and 12.5ml vials. The Patient Information Leaflet (PIL) packed in eleven specified batches does not contain the updated contraception duration requirement, which was extended from four to nine months after cessation of therapy. Affected batches include 3L048A, 3L048I, 4E049Q, 4J050J, 4J050Q, 4J050V, 5B051B, 3C045AA, 3C045Y, 3C045Z, and 5B051A, distributed between July 2024 and October 2025. Healthcare professionals are advised to inform female patients to use contraception for at least nine months after stopping the medication, and updated PILs are available via the Electronic Medicines Compendium or upon request from Baxter.

New MHRA-NICE Aligned Pathway Launches April 1, Cutting Medicine Approval Time by 3-6 Months

The MHRA and NICE are launching an aligned approval pathway on 1 April 2026 that synchronises medicine licensing and value assessment decisions, enabling patients in England to access some new medicines three to six months sooner. Twenty-seven pharmaceutical companies registered as early adopters in October 2025, with the first treatments currently going through the pathway and initial guidance expected in June 2026. Alongside the pathway, both organisations are launching an improved Integrated Scientific Advice service offering a single-entry point, aligned meeting and report structure, and unified payment to help companies clarify regulatory requirements early in development.

Field Safety Notices: 9-13 March 2026

MHRA published six Field Safety Notices (FSNs) for medical devices covering the period 9-13 March 2026. Notices cover devices from Armstrong Medical (APL Valve), Gyrus (Soltive Laser System), ICU Medical (CADD High Volume Administration Sets), Physio-Control Inc (Infant/Child Reduced Energy Defibrillation Electrode), Milestone (Vacuum Bag Su Large), and Trividia Health (TRUE METRIX glucose monitoring systems). The page is published for information only — FSNs must be obtained directly from the manufacturers via the provided links.

MHRA NICE Integrated Scientific Advice Service Guidance

The MHRA and NICE have updated guidance on their Integrated Scientific Advice (ISA) service for medicine developers. The updates provide additional information on preparing for ISA meetings, including specific guidance on writing questions, creating briefing books, and understanding ISA reports and fees.

£1.4bn Opportunity: Medicine Reclassification to Transform Healthcare

The MHRA published a guest blog by PAGB CEO Michelle Riddalls OBE exploring how reclassifying medicines from Prescription-Only Medicine (POM) to Pharmacy (P) and from Pharmacy (P) to General Sales List (GSL) could save the NHS an estimated £1.4 billion annually if prescribing spending were reduced by 5%. The blog, aligned with the NHS 10 Year Health Plan's shift toward prevention, notes that 74% of adults want more medicines available without a prescription and cites prior successful switches including Nurofen, Allevia, Calpol, Estradiol vaginal products, Ovesse estriol cream, and Viagra. PAGB and pharmacy organisations via the Reclassification Alliance are calling on the Government to widen the use of 25 OTC products over the next five years, working with MHRA and DHSC.

MHRA Advertising Investigations: February 2026

The MHRA has published its advertising investigation decisions for February 2026, following investigations into complaints about advertising for licensed medicines. The decisions cover two areas: websites highlighting medicinal treatment services for weight loss, and medicinal treatment services broadly. The page provides contact information for the Advertising Standards Unit and references the self-regulatory bodies PAGB and PMCPA for medicines advertising concerns.

MHRA Approves Deuruxolitinib (Leqselvi) for Severe Alopecia Areata in Adults

The MHRA approved deuruxolitinib (Leqselvi) by Sun Pharma UK Limited on 11 March 2026 for treating severe alopecia areata in adults. The JAK1/JAK2/TYK2 inhibitor was evaluated in two pivotal clinical trials involving 1,223 adult patients, with approximately 30% achieving 80% or more scalp hair coverage and 23% achieving 90% or more after 24 weeks. The most common side effects are headache and acne; the drug is prescription-only at 8 mg twice daily and subject to additional safety monitoring.

UK Agencies Issue Joint Statement Supporting In-Orbit Pharmaceutical Manufacturing

The UK Space Agency, MHRA, Regulatory Innovation Office (RIO) and Civil Aviation Authority (CAA) have issued a joint statement setting out collaborative support for in-orbit manufacturing of pharmaceuticals, citing microgravity's potential to improve drug solubility, purity, crystallisation and stability. The UK Space Agency is funding three in-orbit manufacturing feasibility studies including a £250,000 study for BioOrbit, a start-up designing a scalable in-orbit manufacturing system to crystallise biologic drugs for cancer treatments. The Government is launching a Re-entry Regulatory Sandbox to support re-entry activities such as in-orbit manufacturing.

MHRA Field Safety Notices February 23-27 2026

MHRA published five Field Safety Notices covering devices including an Abiomed Automated Impella Controller update, a Diagnostica Stago protein S IVD assay, a GE HealthCare medical image viewer, an IMACTIS CT-navigational surgical robot, and a Mangar bath lift. The notices were issued between 23-27 February 2026 and published by MHRA on 3 March 2026. The page advises that recipients of FSNs from manufacturers must act on them, though MHRA publishes these notices for information only.

MHRA Statement on Pathways Clinical Trial

The MHRA has issued a public statement reaffirming that participant safety is its top priority in all clinical trials following concerns about the Pathways trial. As a precautionary measure, Professor Jacob George has been recused from further involvement in the Pathways clinical trial after social media posts made prior to his appointment were identified. The MHRA states its multidisciplinary team of medical, scientific, and regulatory experts will continue meeting with King's College London to work through next steps constructively.

MHRA Criminal Enforcement Unit Raids Second Illegal Weight Loss Medicine Facility in Lincolnshire and Nottinghamshire

MHRA Criminal Enforcement Unit officers, supported by Lincolnshire Police, Immigration Enforcement, and Lincolnshire Trading Standards, raided two premises—a farm near Sleaford and a residential address in Grantham—as part of an ongoing investigation into an organized criminal network manufacturing and distributing unlicensed weight loss medicines. Officers seized almost 2,000 doses of unauthorized weight loss medicines awaiting dispatch, alongside manufacturing equipment, suspected pharmaceutical ingredients, packaging, and commercial vehicles. The products included retatrutide, tirzepatide, and peptide products. This operation follows a landmark October 2025 raid in Northampton that dismantled the UK's first illicit weight loss medicine manufacturing facility.

MHRA Approves Imlunestrant Tosylate (Inluryo) for Breast Cancer

The MHRA granted marketing authorisation to imlunestrant tosylate (Inluryo) on 24 February 2026 for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer that has progressed after at least one prior hormonal therapy. The new oral selective oestrogen receptor degrader (SERD) is specifically indicated for patients with ESR1 gene mutations and is manufactured by Eli Lilly Nederland B.V. Common side effects include elevated liver enzymes, fatigue, musculoskeletal pain, and gastrointestinal symptoms; the MHRA will continue monitoring safety as usage expands.

Brensocatib Licensed for Non-Cystic Fibrosis Bronchiectasis in Patients 12 Years and Older

The MHRA has granted a marketing authorisation for brensocatib (Brinsupri) to Insmed Netherlands B.V. for treating non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older who have experienced two or more flare-ups in the past 12 months. Brensocatib works by targeting DPP1, a protein involved in lung inflammation, and is taken as a once-daily oral tablet. The most common side effects include nose and throat infections, diarrhoea, vomiting, headache, gum problems, skin thickening, rash, dermatitis, and hair loss.

MHRA Statement on PATHWAYS Puberty Blocker Trial Safety

The MHRA has issued a statement regarding the PATHWAYS puberty blocker trial, expressing concerns about participant wellbeing and initiating scientific dialogue with the trial sponsor, King's College London. The agency is applying high scrutiny to ensure the safety of potential child and young person participants.

MHRA Approves Zanidatamab for HER2+ Biliary Tract Cancer

The MHRA has approved zanidatamab (Ziihera) for adult patients with HER2-positive biliary tract cancer that has progressed after previous treatment. This approval provides a new treatment option for a specific patient population with an unmet clinical need.