FDA issues an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara System.
FDA authorizes Felix Pharmaceuticals generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.
FDA sends a second complete response letter to Camurus regarding its NDA for Oclaiz (octreotide), an extended-release injection under review for the t...
The Department of Justice says a federal grand jury has indicted the co-owner of Floridas Pine Care Research Center and two staff members on charges t...
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A Health Affairs article discusses clarifications and revisions that it says are needed in an FDA draft guidance describing a plausible mechanism fram...
