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

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

Employees of the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and ...

Bread and rolls sold in six states have been recalled over 'glass fragments,' according to the U.S. Food and Drug ...

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

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

The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...

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

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

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

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

The FDA has approved a monoclonal antibody to treat individuals aged 12 years and older with generalized myasthenia gravis ...