A recall of seafood burgers by the Connecticut based company Caraluzzi's Markets has been issued a Class I risk ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

The US Food and Drug Administration has approved nipocalimab-aahu, a new FcRn- blocking monoclonal antibody, for the ...

The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...

The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia ...

Health and Human Services employees were told in March to remove 'nicknames' from email systems and signatures to comply with ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...

The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...

The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.

Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...

Among other things, Makary breaks some news here by stating, for the first time, that there will be no significant ...