FDA Review posts product approval summaries for the week ending 3/29/2019.
Daiichi Sankyo says it is accelerating the timetable for submitting a BLA for its breast cancer drug [fam-] trastuzumab deruxtecan.
Three top FDA executives urge drug companies to maintain expanded access to drugs for patients who are benefiting from them in a clinical trial after ...
FDA proposes changes to radiological health regulations to clarify and update the regulations by eliminating outdated and duplicative provisions.
FDA and Acadia Pharmaceuticals dispute an Institute for Safe Medication Practices report questioning the safety and efficacy of Acadias Nuplazid Parki...
FDA is implementing a reorganization proposed by outgoing commissioner Scott Gottlieb.
Federal Register notice: FDA awards Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease produc...