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.
The case had been filed last year by Amgen after the state Prescription Drug Affordability Board determined that its big-selling medication called Enbrel is unaffordable and began a process to ...
Based on Wall Street analyst estimates for 2025 EPS, Amgen trades at 15 times its projected earnings, while Merck sits at a forward P/E of 10. By this measure, Merck is the cheaper stock and a ...
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 ...
The Phase III MITIGATE trial demonstrated that Uplizna (inebilizumab) significantly reduces the risk of flares, lowers glucocorticoid dependence, and increases rates of treatment- and ...