Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...

Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...

Amid the sultry summer months, a few signs of fall become apparent, such as the appearance of school supplies on stores ...

Exporting counterfeit medicines is a cruel business that robs ill people of any hope for relief. Cancer patients unknowingly using fake Keytruda would have no chance of improvement with their terminal ...

A Canadian company has recalled varieties of mushrooms that could be contaminated with the dangerous bacteria. Ohio is one of two states the mushrooms were distributed.

The Food and Drug Administration has approved a first of its kind, once-yearly shot designed to protect dogs from fleas and ...

The U.N. warned that millions could die as a result of the Trump administration ending nearly $4 billion for the global HIV ...

The Ozark Trail 64-ounce water bottle sold at Walmart can eject its lid with dangerous force. This design flaw has caused ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

The anti-seizure drug is used to treat epilepsy, nerve pain after shingles and restless legs syndrome by affecting chemical messengers in the brain and nerves.

The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...

My reading of Health and Human Services Director Robert F. Kennedy Jr.’s leadership is a lot different than that espoused by ...