Two stakeholders recommend improvements to an FDA draft guidance on development and labeling of oncology drug companion diagnostic devices.
An FDA safety alert warns consumers about establishments in several states that are offering young-donor plasma infusions to treat various conditions.
FDA approves a Novo Nordisk BLA for Esperoct (turoctocog alfa pegol) for treating adults and children with hemophilia A.
The Justice Department says the government has intervened in a whistleblower case alleging that Arriva Medical submitted false claims to Medicare for ...
FDA Oncology Center of Excellence director Richard Pazdur reviews several drug trials using the pathological complete response rate regulatory endpoin...
FDA releases an FDA-483 with two observations for an inspection at Indias Lupin Limited.
Researchers say inappropriate prescribing of transmucosal immediate release fentanyl products occurred despite a REMS intended to ensure appropriate p...
FDA grants Medtronic a breakthrough device designation for its investigational Personalized Closed Loop insulin pump system.