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 will review a Biogen sNDA for a Spinraza higher dose regimen.
FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Trump Administration E...
Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brain cancer).
