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.
Bausch + Lomb recalls its enVista intraocular lenses after the company received reports of complications, which it says could not immediately be expla...
Six Sidley attorneys raise several practical questions arising from a Texas federal court decision finding that FDA does not have legal authority to r...
FDA grants Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy ...
