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...
Some 100 members of Congress call on HHS to use existing legal authorities to lower drug prices in the U.S.