The Latest Breaking News from FDA

Contamination may have killed one person and injured others, some of whom had eyes removed

The Centres for Disease Control and Prevention has identified a rare strain of Pseudomonas aeruginosa in 68 patients across 16 states in the US due to contaminated eyedrops

Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from US health advisers Thursday, clearing the way for its full regulatory approval by the Food and Drug Administration. The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021.

The feds took on Florida Surgeon General Joseph Ladapo last week in a highly critical letter responding to the state’s top doctor’s fear-mongering claims about COVID vaccine risks.

Many ‘patient influencers’ offer medical advice without always revealing ties to pharmaceutical companies

In the wake of a joint investigation by KHN and CBS News into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, or AGGA, according to a former agency official.

U.S. health advisersare backing the continued use of Pfizer’s COVID-19 pill Paxlovid, saying it remains an important option for adults at high risk of severe illness

A federal judge is poised to restrict mifepristone – even though the drug has been safely and effectively used in the US for more than 20 years

"This type of activity would fundamentally de-stabilize the FDA regulatory system," a legal expert said.

WASHINGTON — A federal district judge heard oral arguments Wednesday in a controversial case that could decide the fate of the Food and Drug Administration’s approval of the abortion drug mifepristone — a decision that would have broad ramifications nationwide.

The case examines whether the FDA erred in its approval of a drug commonly used for both abortions and miscarriage management.