The Trump administration nominates former deputy surgeon general Erica Schwartz to be CDC director, and taps FDA principal deputy commissioner Sara Br...
Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...
A House hearing on HHS budget sees lawmakers repeatedly questioning secretary Robert F. Kennedy Jr. on FDA issues, including drug regulation, approval...
CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.
FDA plans a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agencys bulk drugs for compounding list....
An FDA town hall gives a detailed explanation of the new medical device Quality Management System Regulation and answers frequently asked questions ab...
The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to reflect all of the ...
FDA extends until 11/22 its review of a Savara BLA for molgramostim to treat autoimmune pulmonary alveolar proteinosis.
