MHRA Chair welcomes re-appointment of three non-executive directors
Professor Anthony Harnden has congratulated the trio of Agency board members on the extension of their appointments.
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BsUFA IV: Fiscal Years 2028-2032
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. -
Gepotidacin – Oral Products
Gepotidacin – Oral Products -
Breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
Information for patients, public and healthcare professionals.
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Mirdametinib approved to treat plexiform neurofibromas in children, adolescents, and adults with neurofibromatosis type 1
As with any medicine, the MHRA will keep the safety and effectiveness of mirdametinib under close review.
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MediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial Contamination
FOR IMMEDIATE RELEASE – December 10, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, a -
BAKKAVOR USA Issues Allergy Alert for 16-Ounce Meal Simple Red Lentil Dal Soup Due to Undeclared Milk
Charlotte, NC (December 9, 2025) – Bakkavor USA of Charlotte, North Carolina, is initiating a recall of 16-ounce Meal Simple brand Red Lentil Dal Soup, BEST BY 1/11/2026 as it contains undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threateni -
Lunds & Byerlys Voluntary Recalls L&B Monster Cookies Due to Incorrect Labeling
EDINA, Minn., December 9, 2025 – Lunds & Byerlys is voluntarily recalling its L&B Monster Cookies as the wrong ingredient label was applied to the packaging. Packages may contain undeclared peanuts, egg, and soy. People who have allergies to peanuts, egg, and soy run the -
Early Alert: Anesthesia System Issue from GE HealthCare
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems -
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers
The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products. -
Astellas Pharma Inc. – 06/06/2025
Astellas Pharma Inc. – 06/06/2025. Country: Japan. Record Type: 483 -
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.