The Washington Post says FDA commissioner Scott Gottlieb is worried about the effect of negative messages coming from supporters of branded biologics ...
Sun Pharmaceutical Industries recalls four lots of vecuronium bromide for injection because they have been found to contain particulate matter identif...
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.
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...