The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George ...
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to ...
Developers of biosimilars -- medicines that are near-identical copies of biologic drugs -- will no longer be required to conduct clinical trials to prove effectiveness.
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), ...
Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent ...
Green Matters on MSN
FDA Recalls More Than 140,000 Bottles of Cholesterol Medications Due to High Health Risk They Pose
Massive recall of 141,984 bottles of Cholesterol medicine gets an update. In September, the Food and Drug Administration ...
While most of what the FDA laid out in a recent draft guidance on the assessment of overall survival in oncology clinical ...
Career scientists at the Food and Drug Administration say Trump administration officials are compromising their ability to practice legitimate science. Here & Now's Robin Young speaks with STAT's ...
WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback