FDA accepts for priority review an Alexion Pharmacuticals supplemental BLA for Ultomiris (ravulizumab-cwvz), the companys long-acting C5 complement in...
Sen. Chuck Grassley says he opposes a Trump administration proposal to tie prices Medicare pays for some drugs to the lower prices paid in other count...
CDERs Office of Prescription Drug Promotion solicits comments on two proposed research studies on comprehension of oncology indications in TV ads.
The CDER Office of Prescription Drug Promotion sends a notice of violation to Aclaris for a video and associated materials that it says minimizes the ...
Opko Health submits a de novo request to FDA seeking regulatory clearance for the 4Kscore, a blood test for intended use by health care professionals ...
International Academy of Compounding Pharmacists executive Scott Brunner calls on FDA to revises the way it is implementing the Drug Quality and Secur...
FDA says it is developing new tools to aid in evaluating peptides and their generic alternatives.
Stakeholders comment on potential changes to an FDA benefit/risk evaluation assessment framework.