Red states claiming "sovereign injury" seek to impose nationwide restrictions.

FDA Principal Deputy Commissioner Sara Brenner and Tracy Beth Høeg, then special assistant to the commissioner, wrote the scientific analyses underlying HHS' May 2025 decision to eliminate the recomme...

The layoffs announced last week at the Washington Post were disfiguring to the esteemed news organization, with whole sections and departments—sports, books, staff photography—wiped away, and devastat...

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.

On Friday, Dr. Peter Marks announced his resignation from the U.S. Food and Drug Administration (FDA) as Director of CEBR (Center for Biologics Evaluation and Research) citing differences with Health

Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdow...

This Viewpoint discusses the Trump administration’s firings of thousands of US Food and Drug Administration employees and the ramifications of those actions on the agency’s congressionally given publi...

Among those now leaving the US FDA’s biologics center is Lola Fashoyin-Aje, who was considered a rising star at the agency when she became director of the Office of Therapeutic Products’ Office of Cli...

Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.

A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidentia...

A Trump Administration communications freeze and travel ban may be complicating efforts to convene FDA advisory committees. A 5 February meeting on postmarketing requirements for extended-release/long...

The FDA's interim leadership takes shape, but the sense of transition chaos still lingers.

The two-time FDA commissioner resigned on 20 January as part of the administration change. Califf is credited with righting an agency demoralized from the COVID-19 pandemic, but worries about its futu...

Under federal district court orders announced today, the co-founders of the Stem Cell Institute of America and several related companies are banned from marketing stem cell therapy in the future.

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that the...