The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

An audit released by the Inspector General of the U.S. Department of Health and Human Services, the parent organization of the Food and Drug Administration (FDA), is not a pleasant read. Let us turn ...

It’s not clear if the changes are temporary or if the pages will be restored. When asked about the removed webpages, an FDA spokesperson directed MedTech Dive to contact the Department of Health and ...

The page for Project Equity, a 2021 initiative launched by the FDA's Oncology Center of Excellence to ensure that cancer drugs were evaluated for approval based on data from a diverse group of ...

As of the FDA's last update on Jan. 15, authorities were investigating multiple outbreaks of E. coli and Listeria. Publication of the Centers for Disease Control and Prevention's authoritative ...

The FDA's Diversity Action Plan draft guidance to drug and medical device companies stems from the 2022 Food and Drug Omnibus Reform Act. It aims to significantly increase participation of ...

While this falls short of the FDA’s designation of being “approved” as generally safe, it allows ZYN to continue selling its three- and six-milligram nicotine pouches in 10 different flavors ...

The FDA declined to comment, citing a communications pause by the HHS. Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins ...

The FDA first approved the Johnson & Johnson drug, called Spravato (esketamine), for some cases of depression in 2019, but it was only allowed to be prescribed alongside an oral antidepressant. After ...