Several drug companies respond to FDAs request for comments on how to proceed with Bendeka orphan drug exclusivity in light of a court ruling.
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Kirin-Amgens Siliq (brodalumab).
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Radius Healths Tymlos (abaloparatide).
A federal judge enters a consent decree banning Tennessees Keystone Laboratories from marketing its OTC products until its facility complies with the ...
FDA says that during the recent International Internet Week of Action it targeted 465 Web sites that illegally sold potentially dangerous, unapproved ...
FDA releases its latest batch of Warning Letters that includes one medical product company Auro Pharmacies.
A new safety alert warns against an increased risk of corneal haze associated with Optics Medicals Raindrop Near Vision Inlay.
FDA extends by three months its review of a Bristol-Myers Squibb supplemental BLA for an indication in metastatic first-line non-small cell lung cance...