Pfizer agrees to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in previous illegal kickback schemes.
Vanda Pharmaceuticals files an NDA for tradipitant for treating motion sickness.
FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Navigation Software Version 3.0, which the company says introduces an intraoperative computed ...
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...
