Georgia's congressional delegation is advocating for FDA reconsideration of the drug elamipretide for Hope Filchak.

After 100 days as FDA Commissioner, Dr. Marty Makary lays out his vision for reform, starting with the broken systems he's ...

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

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

LIV Golf has applied again to be included in the Official World Golf Ranking, without any indication how it will operate ...

The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...