The Phase III MITIGATE trial demonstrated that Uplizna (inebilizumab) significantly reduces the risk of flares, lowers ...

In the coming two weeks, the FDA is expected to announce three big decisions, including one for a dry eye disease therapy.

These are data to week 26 on the monoclonal antibody and antineoplastic agent; data out to week 52 of the MINT trial will be ...

As Amgen waits for an FDA decision on a second indication for its B cell-depleting therapy Uplizna, it has new data suggesting a third may be coming down the pipe. New data from the phase 3 MINT ...

Amgen is preparing to file a third indication for Uplizna, as a twice-yearly therapy for generalised myasthenia gravis, following new phase 3 data.

Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat ...