Former FDA commissioner David Kessler tells a House hearing that recent FDA staff cuts will adversely affect the U.S.s public health and scientific le...
The Minneapolis Star Tribune says medical device companies are concerned that FDA layoffs have resulted in fewer device approvals in the first quarter...
FDA regulatory experts warn that the agencys user fee programs could be in jeopardy based on sweeping layoffs and political indifference which threate...
Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use disorder in drug manuf...
ZyVersa Therapeutics says a new regulatory development could significantly shorten the path to approval for treatments targeting focal segmental glome...
Three former FDAers warn of a slow-moving catastrophe coming for the agency as it loses staff and resources under leaders who have unconventional view...
FDA approves Bristol Myers Squibbs combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating certain adult and pediatric patients 12 yea...
FDA warns Lawrenceville, NJ-based EpiCare Acquisitions about Quality System and other violations in its manufacturing of a family of laser systems.