Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label expansion for leucovorin to treat the ultrarare cerebral folate deficiency.

FDA worked with GSK to update Wellcovorin labelling for safe, effective use in adult and paediatric CFD-FOLR1 patients.

Marketing Surveillance (PMS), often referred to as Phase IV clinical trials, is the systematic and ongoing monitoring of a drug's safety, efficacy, and real-world performance after it receives ...

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.