Pharmaceuticals announced that the U.S. FDA has approved Revuforj as the first and only menin inhibitor for the treatment of ...

John Jenkins, director of the FDA's Office of New Drugs (OND), cautions ... such products may help explain why the majority of NME and BLA approvals this year were for specialist-care indications ...

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The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...

The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal heart rhythm, the company said on Thursday. The U.S. Food and Drug ...

were approved by the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research in the past year. This is the highest annual total since 1996. Globally, NME approvals ...

A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...

after the US Food and Drug Administration (FDA) approved a supplemental new drug application. The expanded approval for the oral suspension is for the treatment of sudden muscle weakness ...