FDA clears a Fresenius Medical Care 510(k) for VersiHD with GuideMe Software, a self-guided interface for the companys VersiHD chronic home hemodialys...
FDA grants Redx an orphan drug designation for zelasudil (RXC007) for treating idiopathic pulmonary fibrosis.
Medtronic issues an Urgent Medical Device Communication about its HeartWare Ventricular Assist Device (HVAD) systems and a newly identified subgroup o...
Merck and Eisai terminate the Phase 3 LEAP-010 trial evaluating Mercks Keytruda (pembrolizumab) plus Eisais Lenvima (lenvatinib) in the first-line tre...
Ropes & Gray attorneys break down a new FDA final guidance on informed consent, highlighting changes from a previous draft.
FDA approves a Gilead Veklury sNDA eliminating the need for dose adjustments when treating Covid-19 in patients with mild, moderate, or severe hepatic...
Akebia Therapeutics says it plans to resubmit an NDA to FDA for vadadustat to treat anemia due to chronic kidney disease.
FDA grants Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment combination product for treating infrarenal ...
