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European regulators greenlight Fractyl Health’s clinical test of GLP-1 gene therapy

May 13, 2026
European regulators have approved Fractyl Health’s clinical trial for a novel GLP-1 gene therapy, a significant milestone in the evolving landscape of diabetes treatment. This approval comes at a time when the pharmaceutical industry is increasingly focused on innovative therapies that aim to replace the need for chronic GLP-1 injections and oral medications with a…

MHRA Invites Views on Proposed Changes to Medical Device Regulation

May 13, 2026
New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published by the Medicines and Healthcare products Regulatory Agency (MHRA). This initiative reflects the ongoing evolution of the regulatory landscape in the UK, particularly following Brexit, which has necessitated a reassessment of existing frameworks to ensure safety…

FDA Locks Down Post-Approval Pregnancy Safety Data Framework

May 13, 2026
The FDA has established a new framework for post-approval safety studies focused on the effects of drugs during pregnancy and lactation. This initiative is critical as substantial knowledge gaps persist regarding the efficacy and safety profiles of various pharmaceuticals when used by pregnant or breastfeeding women. The agency’s guidance aims to standardize the collection and…

Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets, EL(26)A/23

May 13, 2026
Milpharm Limited has issued a Class 4 Medicines Defect Notification concerning a discrepancy in the Patient Information Leaflet (PIL) for its Loperamide hydrochloride 2 mg Orodispersible Tablets. This notification underscores the importance of accurate patient information in pharmaceutical products, as any deviation can lead to potential misunderstandings regarding usage and safety. The identification of this…

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