FDA seeks expansion of testosterone replacement therapy use, encouraging drugmakers to explore whether existing products could be approved to treat lo...
An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen...
AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.
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...
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 ...
