Company focused on obtaining approval for outpatient (at-home) use of IGALMI® for the acute treatment of agitation associated ...

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

SHELTON, CT / ACCESS Newswire / July 21, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.: NNVC ) (the ...

The submission is supported by four Phase III clinical trials, which showed that icotrokinra demonstrated significant skin ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

The Trump administration’s proposed cuts at the National Institutes of Health and Food and Drug Administration could lower ...

An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

The US Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

The trial is scheduled to commence in the fourth quarter of this year, with subject recruitment in both Europe and the US.

The application is supported by data from 2 randomized, open-label, multicenter phase 3 clinical studies (NCT04292730 and NCT04292899) conducted by Gilead and a randomized, placebo-controlled ...

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