As Australians face roadblocks to find clinical trials, doctors are calling for a reform of the system to improve access to ...

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

Bayer BAYRY announced that the FDA has granted full approval to oncology drug, Vitrakvi (larotrectinib), a first-in-class TRK ...

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...

The 2018 accelerated approval of Vitrakvi was converted to full approval based on results from three trials in adult and pediatric patients.