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 ...

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

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 ...

Hoagie rolls and sourdough and whole grain multigrain loaves from Upper Crust Bakery LP have all been recalled ...

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 ...

An urgent recall for hundreds of cases of frozen bread sold throughout the U.S. was issued after the FDA said "glass ...

The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...

The company has predicted that Imaavy — now approved for generalized myasthenia gravis — could eventually earn more than $5 ...