FDA accepts for review a Clinuvel Pharmaceuticals 505(b)(2) NDA for Scenesse (afamelanotide) 16mg for preventing phototoxicity and anaphylactoid react...
CDERs Office of Prescription Drug Promotions says its review of some voluntary submissions has slowed because the materials raise complex issues.
Former Insys Therapeutics CEO Michael Babich pleads guilty in Massachusetts federal court for his role in a nationwide scheme to bribe physicians to u...
FDA warns Akorn about CGMP violations in the production of finished pharmaceuticals at its Decatur, IL, facility.
Sens. Grassley and Klobuchar reintroduce legislation to end so-called pay for delay agreements in which innovator drug companies pay potential generic...
SightGlass Vision, a medical device company developing spectacle lenses to slow the progression of nearsightedness or myopia in children, gains cleara...
Public Citizen says it backs legislation introduced by Sen. Bernie Sanders to require HHS to license generic and biosimilar competition in certain ins...
FDA asks members of two advisory committees to reevaluate the benefit/risk profile of Takedas Uloric in light of results of the CARES post-marketing s...