A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
The FDA can’t indefinitely delay the production of documents related to its emergency approval of the Pfizer Covid-19 vaccine ...
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) finalized the guidance on ...
On January 7, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance document titled “Communications From Firms to ...
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral ...
An FDA advisory committee may have ruled in elamipretide’s favor back in October, but it looks like Stealth BioTherapeutics ...
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...
The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of ...
The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression.
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
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