Mustang Bio shares more than quadrupled, to $5.23, after the company on Monday said the Food and Drug Administration granted orphan drug designation to Mustang for MB-101 for the treatment of ...

KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...

Below, we highlight three promising frameworks that provide valuable guidance and resources for assessing AI chatbots in ...

The fact that lenacapavir will soon be available to patients is a testament to the strength of America's biopharmaceutical ...

Johnson & Johnson’s Abiomed has recalled automated controllers for its Impella heart pumps over a fault linked to three ...

After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in ...

The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals' Ekterly (sebetralstat) as the first and only ...

Doctors say the situation forces them to get creative in treating patients, but there’s hope that prices may fall more in the ...

Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

The steady erosion of experienced staff is slowly compromising FDA work and low morale is pushing more workers to the exit ...