FDA clears a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software.
Vanda Pharmaceuticals agrees to settle an off-label marketing case for $11.5 million.
A federal jury convicts former clinical researcher for making a false statement to a government investigator related to her role in a clinical trial t...
The Department of Justice says its top priority for corporate criminal enforcement is individual accountability by targeting the individuals who commi...
Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY).
Federal Register notice: FDA announces an 11/16 advisory committee meeting to discuss an Ardelyx NDA for tenapanor hydrochloride tablets.
FDA approves a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea and vomiting in adul...
Federal Register notice: FDA releases a final guidance entitled Q3D(R2) Guideline for Elemental Impurities.
