FDA grants Sangamo Therapeutics a fast track designation for SB-525, a clinical stage complementary-DNA gene therapy candidate for hemophilia A.
FDA releases its latest batch of Warning Letters that includes Howard Phillips LLC., International Medsurg Connection, Oxford Performance Materials, V...
FDA approves a Pharmadax ANDA for a generic copy of Seroquel XR (quetiapine fumarate) extended release tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 ...
Attorney Matthew Curley looks at False Claims Act suits over speaker programs and other potential areas of liability for drug and medical device manuf...
Eleven Democratic senators call on the president not to hurt implementation of the 21st Century Cures Act through budget cuts and workforce reductions...
The CDER Office of Generic Drugs releases the names of 21 generic drugs for which product-specific guidances have been added.
FDA says it is requiring addition of a Boxed Warning to labeling for the diabetes drug canagliflozin due to increased risk of leg and foot amputation.
FDA approves an Alucent Medical Phase 1 clinical trial of Natural Vascular Scaffolding, a novel combination drug/device therapy for treating periphera...