Kadmon Holdings gets FDA meeting minutes on a planned NDA submission for KD025 for treating patients with chronic graft-versus-host disease.
FDA issues an immediately effective enforcement discretion policy for some digital medical devices used to treat psychiatric disorders during the pand...
FDA issues Herbs of Kedem a Warning Letter after reviewing the companys Web site and determining that it is offering for sale unapproved new drugs for...
FDA extends its deadline until 6/5 to apply for a funding opportunity to examine the use of real-world data to generate real-world evidence in regulat...
FDA commissioner Steve Hahn indirectly contradicts President Trump, telling ABC News that ramping up caronavirus testing, both diagnostic and new anti...
FDA allows the use of home-use blood glucose meters by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose le...
Federal Register notice: FDA makes available two final guidances entitled Guidance on Chloroquine Phosphate and Guidance on Hydroxychloroquine Sulfate...
A just-published study report on the compassionate use of Gileads investigational remdesivir in Covid-19 patients shows improvement in oxygen-support ...