CDER asks for comments on its proposal to withdraw Oncopeptides accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide).
CDRH announces the qualification of a new tool through the agencys voluntary Medical Device Development Tools program: Accelerated Testing to Prove Lo...
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...
