FDA lifts a clinical hold against Voyager Therapeutics and its planned clinical trial for VY-HTT01 for treating Huntingtons disease.
President Biden signs into law two FDA-related bills that are intended to help lower drug/biologic prices.
FDA removes a clinical hold against UniQures hemophilia B gene therapy program after determining it satisfactorily addressed all issues identified by ...
Becton, Dickinson files a 510(k) for the BD Alaris System that updates the infusion pump to address FDA regulatory issues raised last year.
The House Energy and Commerce Health Subcommittee announces a 5/4 hearing to discuss legislative proposals to lower prescription drug costs.
FDA announces a 6/9 workshop entitled The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021.
FDA says it supports increasing use of pharmacometric models in drug development because they allow a better understanding of drug effects in individu...