FDA accepts for review two Merck NDAs for doravirine, the companys investigational non-nucleoside reverse transcriptase inhibitor for treating HIV-1 i...
FDA clears an STS Medical 510(k) for its composite sinus stent.
A new study suggests that pregnant women who take certain drugs for treating attention deficit hyperactivity disorder have a higher risk that their ba...
FDA Review posts the Federal Register notices for the week ending 1/5/2018.
FDA commissioner Scott Gottlieb says production of critically needed drugs in Puerto Rico is improving and shortages may soon begin to ease.
FDA approves an Amgen supplemental BLA for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events...
BioCardia files an IDE for the CardiAMP Chronic Myocardial Ischemia Trial to treat patients with refractory angina.
FDA approves Roches cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing.