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 extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndro...
FDA grants Zai Lab an orphan drug designation to ZL-1310, an antibody-drug conjugate for treating small cell lung cancer.
Three Ropes & Gray attorneys review major FDA-related enforcement cases in 2024 and say it is impossible to predict with certainty the direction the n...
Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.
