FDA approves labeling changes for Haleons OTC weight loss drug alli to warn of the rare risk of kidney injury associated with its use.
The United States Pharmacopoeia 2025 annual drug shortage report documents a reduction in the number of drug shortages but an increase in the time dur...
A Windels Marx petition asks FDA not to approve any ANDA for dabrafenib mesylate using the 505(j)(2)(C) pathway that doesnt include in vivo bioequival...
A Health Affairs article discusses clarifications and revisions that it says are needed in an FDA draft guidance describing a plausible mechanism fram...
Three Akin Gump attorneys highlight some changes in a 2026 FDA draft guidance on communicating healthcare economic information from its 2018 final gui...
FDA extends the comment period by 30 days for its request for information on drug repurposing for unmet medical needs.
FDA approves an expanded dosing regimen for Lillys atopic dermatitis treatment Ebglyss (lebrikizumab-lbkz), allowing certain patients with moderate-to...
FDA sends an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and quality oversight a...
