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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…

Partner’s bispecific Bizengri nabs FDA national priority nod in rare bile duct cancer

May 13, 2026
Bizengri, a bispecific therapeutic developed by a leading partner, has received national priority designation from the FDA for its application in treating rare bile duct cancer. This marks the seventh approval under the FDA’s U.S. national priority pilot program, which aims to expedite the review process for drugs addressing unmet medical needs. The rapid approval…

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