FDA approves Amgens Blincyto (blinatumomab) for treating adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precu...
Federal Register notice: FDA announces a 10/30 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on patient-cen...
Three stakeholders ask FDA to modify a draft guidance on the agencys platform technology designation guidance.
Federal Register notice: FDA determines that Exela Pharma Sciences diltiazem HCl in dextrose, 125mg/125mL and 250mg/250mL were not withdrawn from sale...
Federal Register notice: FDA announces the withdrawal of two Mammography Quality Standards Act (MQSA) alternative standards due to updated MQSA regula...
FDA grants BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory chronic lymphocytic leukemia or sm...
FDA clears an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes (ages 18 years and ...
A group of researchers find that about half of the over 500 AI devices allowed to enter the market since 2016 lack reported clinical validation data.
