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

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

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

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

President Donald Trump's proposed budget cuts to the National Institutes of Health would eventually result in fewer drugs on ...

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review ...

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ...

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its investigational oral peptide, icotrokinra, for treating moderate-to-severe plaque ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

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

Small molecule drugs are low-molecular-weight, organic compounds used to treat a wide range of conditions. Here's what you should know.