Pennsylvania-based medical device manufacturer Biocompatibles pleads guilty to misbranding its embolic device LC Bead and will pay more than $36 milli...
FDA approves a Gilead Sciences NDA for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus inf...
FDA grants Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for treating patients with CD30-expressing mycosis f...
Retrophin reaches an agreement with FDA under a Special Protocol Assessment for a Phase 3 clinical trial evaluating RE-024, an investigational replac...
President-elect Donald Trump reportedly selected former HHS official Andrew Bremberg to lead the transition team for HHS.
Former FDAer Wayne Pines outlines three impacts of the election results on FDA in the future.
The HHS Inspector General releases a 2017 work plan with five items relating to FDA oversight of drugs and medical devices.
FDA denies on procedural grounds a Virtus Pharmaceutical petition asking it to investigate whether two producers of potassium chloride oral solution p...