Harvard Medical School researchers outline several steps that FDA and Congress could take to increase the number of biosimilars available to patients.
FDA clears a Lumendi 510(k) for its DiLumen EIP technology with suture loops placed in the skirt along the trailing edge of the fore balloon, a modifi...
FDA accepts for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation.
FDA warns US Vascular about Quality System and Medical Device Reporting violations in its production of VascuLab devices used in vascular pathology.
FDA warns StemGenex about multiple violations in its production of a stromal vascular fraction product.
FDA describes professional promotion research it wants to conduct about oncology drug disclosures.
The Stericycle Recall Index for the third quarter of 2018 shows an increase in drug recalls and a decrease in medical device recalls.
FDA accepts for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) plus chemotherapy for first-line treatment of unresectable l...