FDA lifts a clinical hold on Alnylam Pharmaceuticals clinical studies with fitusiran, indicated for treating patients with hemophilia.
Federal Register notice: FDA makes available a draft guidance entitled The Least Burdensome Provisions: Concept and Principles that intends to elimina...
Federal Register notice: FDA issues a priority review voucher to Ultragenyx Pharmaceutical for obtaining approval of a rare pediatric disease product ...
Federal Register correction notice: FDA corrects an 11/27 notice entitled Safety Assessment for Investigational New Drug Safety Reporting; Public Work...
Citing correspondence addressed to then-new commissioner Scott Gottlieb, the Project On Government Oversight questions how biotech executive John F. C...
Medtronic agrees to a $12 million settlement with five states over alleged deceptive promotion of its Infuse bone graft system.
FDA publishes a draft guidance explaining its view of Congress requirement that it apply least burdensome principles to medical device review.
FDA scientists say it is possible to standardize high throughput sequencing to screen biologics for contamination.