Two Sheppard Mullin attorneys say sponsors of drugs approved through expedited pathways should learn from a recent FDA untitled letter faulting Mirais...
FDA clears Cresilons Traumagel device that uses a plant-based technology to control moderate to severe bleeding at the point of care.
FDA describes CDERs new state-of-the-art advanced manufacturing research facility.
FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in certain patients with limited-stage small cell...
FDA grants Wave Life Sciences a rare pediatric disease designation for WVE-N531 and its use in treating boys with Duchenne muscular dystrophy.
FDA approves a Vericel supplemental BLA for NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness or full-th...
Two stakeholders respond to an FDA request for comments on the agencys recent listening session on advisory committees and their governing processes.
Gardner Law says prescription drug manufacturers and marketers need to be sure their social media promotions can withstand FDA scrutiny pushed by Cong...
