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 ...

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

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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 and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and ...

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 ...

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 ...

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