The FDA rolled out a generative AI tool for speeding regulatory reviews, announcing its launch nearly a month ahead of a June ...

The Food and Drug Administration commissioner repeatedly said patients should rely on guidance from their doctors.

FDA Commissioner Marty Makary defended the U.S. federal health agencies recent removal of the COVID-19 vaccine from the ...

The FDA picked the LP.8.1 Covid strain for the fall vaccines, fueling concerns that the shots may be limited to only the most ...

The agency recommends manufacturers update their vaccines to target the JN.1 strain. At the same time, HHS head Robert F.

In 2018, the FDA began an investigation into nitrosamine impurities in drugs that led to high-profile recalls for heartburn ...

The vaccine eligibility change is a threat to the health of Americans, some experts say, adding that the FDA is not being ...

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC ...

The FDA rejected Stealth BioTherapeutics’ latest bid to market its proposed treatment for an ultra-rare genetic condition, ...

At CTO West Coast, an expert discussed the implications of the FDA’s expedited approval programmes with a spotlight on ...

The Centers for Disease Control and Prevention has issued updated advice on the COVID-19 vaccine days after Health and Human ...