The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML.

The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab ...

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...

To achieve these ends, the FDA will use computer modeling and artificial intelligence (AI) to predict a drug’s behavior and ...

In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a ...

The nonprofit Physicians Committee for Responsible Medicine, which promotes the use of human-relevant test methods to replace ...

The company stated that the FDA noted at least one additional adequate and well controlled study to demonstrate a positive ...

Treatments for COPD, psoriasis, and neuroendocrine tumors, as well as a next-generation COVID-19 vaccine are under review.

The U.S. Food and Drug Administration (FDA) has announced an ambitious effort to modernize drug testing by reducing reliance ...

Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...

ST-001, an intravenous nanoformulation of fenretinide, will be evaluated in a phase 1a/1b small cell lung cancer trial.

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending ...