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

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 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 ...

Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel ...

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 ...

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 ...

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

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