MHRA approves zanidatamab (Ziihera) for the treatment of biliary tract cancer
Zanidatamab is used when the cancer cannot be removed by surgery and has spread to nearby tissues or other parts of the body.
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UK medical device testing hits record high as MHRA backs growth in brain and AI technology
Patients benefit from earlier access to technologies that could improve or save lives, as the MHRA approved 17 per cent more clinical investigations in 2025 compared with 2024, and launches measures to support innovation and growth.
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Lupin Limited – 11/21/2025
Lupin Limited – 11/21/2025. Country: India. Record Type: 483 -
Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities -
Bertrand P. Cole, D.O. – 723495 – 02/02/2026
Clinical Investigator -
Go Raw, LLC. Issues Voluntary Recall of a Single Lot of Quest Cat Food Chicken Recipe Freeze Dried Nuggets Due to Low Levels of Thiamine (Vitamin B1)
Go Raw LLC is voluntarily recalling a single lot of Quest Cat Food Chicken Recipe Freeze Dried Nuggets, 10oz bag, lot code #C25288, Best Buy Date 10/15/2027, because it may contain low levels of thiamine (Vitamin B1). -
Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately -
2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee)
2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) -
Bertrand P. Cole, D.O./Activmed Practices and Research, LLC – 723495 – 02/02/2026
Clinical Investigator -
Cosmetic Manufacturers Pty Ltd. – 719225 – 02/06/2026
CGMP/Finished Pharmaceuticals/Adulterated -
Field Safety Notices: 09-13 February 2026
A list of Field Safety Notices: 09-13 February 2026
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Class 3 Medicines Recall: Norgine Limited, MOVICOL Ease Citrus Powder for oral solution 13.7 g, EL(26)A/08
Norgine Limited is recalling one batch of product as a precautionary measure due to some units containing low amounts of active ingredients.