ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on positive updated data from the A...
FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transpl...
Responding to a Trump Administration order, FDA delays the effective date until 3/21 of a recent final rule entitled Nonprescription Drug Product With...
HHS elevates CDRH chief medical officer for in vitro diagnostics Sara Brenner to FDA acting commissioner under the Trump Administration.
Merck and Eisai say results from the Phase 3 LEAP-015 trial evaluating Keytruda plus Lenvima in gastroesophageal adenocarcinoma patients missed its en...
FDA grants Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging prostate cancer lesions in p...
Caranx Medical files a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve implantation.
FDA extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndro...
