The U.S. Food and Drug Administration has flagged three of Philips' medical device facilities after inspections found they ...

The U.S. Food and Drug Administration has approved Lynkuet, a new medication that does not contain hormones to treat hot ...

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Augurex Life Sciences’ SPINEstat ...

Nearly 142,000 bottles of atorvastatin calcium tablets recalled nationwide • Faulty dissolution may limit drug absorption and ...

The FDA approved a label update for Winrevair to include that it lowers the risk for clinical worsening events in adults with ...

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in ...

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...

If approved, it would be the first major new drug treatment for Parkinson’s in half a century. Richard Mailman, a University ...

The FDA has approved Lynkuet, a revolutionary non-hormonal medication, to alleviate moderate-to-severe hot flashes and night ...

For a full list of the manufacturer codes and label images, visit the FDA website.

The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...

The vast majority of FDA employees keep working during a government shutdown. According to its updated contingency plans, about 10,700 employees, or 66% of its workforce, are exempt, meaning they ...