Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Imclones Lartruvo.
FDA publishes a draft guidance to assist sponsors who develop drug products that may result in testicular toxicity.
FDA deputy commissioner Anna Abram tells the JAX Healthcare Forum how innovation is part of FDAs DNA.
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Genentechs Tecentriq (atezolizumab), in...
Federal Register notice: FDA submits to OMB an information collection extension for its guidance on Formal Meetings With Sponsors and Applicants for P...
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Wyeths Besponsa (inotuzumab ozogamicin)...
FDA warns Californias Auro Pharmacies about multiple violations in its drug compounding operations.
FDA commissioner Scott Gottlieb says two advisory committees will discuss ways to make naloxone more readily available to combat opioid overdoses.