UCB petitions FDA not to approve an Apotex ANDA for generic Fintepla unless its labeling includes specified information from the reference-listed drug...
FDA accepts for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombocytopenic purpura.
Prothena says it has appointed former CDER Office of Neuroscience director Billy Dunn to its board of directors.
An attorney who works for a company regulated by FDA asks the DC federal court to stop the agency from publishing the attorneys name and identifying i...
Phoenix, AZ-based Pharmedica USA tells FDA it will stop all drug production and distribution after the agency finds CGMP violations during an inspecti...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Intact Vasculars Tack Endovascular System....
FDA releases the form FDA-483 with three observations issued following an April inspection at the Ipca Laboratories drug manufacturing facility in Hav...
FDA warns Waxahachie, TX-based Sea-Long Medical Systems about multiple Quality System regulation violations in its production of misbranded and adulte...
