FDA publishes a draft guidance to help sponsors develop fit-for-purpose clinical outcome assessment measures of patients health that are appropriate t...
Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for ViiV Healthcares Rukobia (fostemsavir trometh...
Federal Register notice: FDA determines for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics Danyelza (naxitamab-...
FDA sets 2/28/23 as the target date for its review of a Regeneron sBLA for a 167-week dosing regimen of Eylea in patients with diabetic retinopathy.
A Duane Morris legal alert says the Justice Department is showing a renewed interest in fraud-on-FDA cases.
The HHS Inspector General says FDA agrees with its recommendations to improve foreign for-cause drug inspections.
FDA clears an Invictus Sterilization 510(k) for the Aura Storm ultraviolet medical air purifier that is intended to inactivate bacteria and viruses (e...
Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy has been postponed by four to six months aft...