FDA grants BrainQs artificial intelligence-powered technology for ischemic strokes a breakthrough device designation.
A provision in a budget reconciliation bill moving its way through the U.S. House of Representatives provides FDA with a $500 million boost for Covid-...
Moderna says it discussing with FDA a proposal to increase Covid-19 vaccine doses in each vial from 10 to 15 doses.
Ndal Mfg Inc. recalls one lot of Manukaguard Allercleanse after determining the products were contaminated with yeast.
FDA classifies as Class 1 a Boston Scientific recall of its Emblem S-ICD subcutaneous electrode because of an increased risk of fractures at the dista...
FDA clears an Access Vascular 510(k) for its HydroMID midline catheter, which is made using the companys proprietary biomaterial that it says has been...
CDERs Office of Pharmaceutical Quality says that early this year it will begin using its Knowledge-aided Assessment & Structured Application (KASA) to...
The Office of Generic Drugs annual report says it approved 948 ANDAs during 2020 -- down 223 or 19% deom the previous year -- while also approving man...