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FDA accepts for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombo...[ Price : $8.95]
Prothena says it has appointed former CDER Office of Neuroscience director Billy Dunn to its board of directors.[ Price : $8.95]
An attorney who works for a company regulated by FDA asks the DC federal court to stop the agency from publishing the attorneys na...[ Price : $8.95]
Phoenix, AZ-based Pharmedica USA tells FDA it will stop all drug production and distribution after the agency finds CGMP violation...[ Price : $8.95]
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Intact Vasculars Tack ...[ Price : $8.95]
FDA releases the form FDA-483 with three observations issued following an April inspection at the Ipca Laboratories drug manufactu...[ Price : $8.95]
FDA warns Waxahachie, TX-based Sea-Long Medical Systems about multiple Quality System regulation violations in its production of m...[ Price : $8.95]
The Bespoke Gene Therapy Consortium, of which FDA is a member, chooses eight rare diseases for a clinical trial portfolio intended...