FDA asks Helius Medical Technologies for more information to support its request for de novo clearance of its portable neuromodulation stimulator.
The Justice Department announces a global settlement with Purdue Pharma and the Sackler family worth more than $8.3 billion.
Covid-19 vaccine watchers expect FDA to soon remove a clinical hold on AstraZenecas Covid-19 vaccine trial after it completed its review of a serious ...
FDA warns RLC Labs about CGMP and other violations in its production of unapproved biologic products.
Merck reports positive findings from two Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the companys investigational ...
Three Hyman, Phelps attorneys say one good thing to come out of the pandemic could be FDA adoption of principles of fairness in an executive order and...
Federal Register notice: FDA issues an order debarring Keith Komar for five years from importing or offering for import any drug into the U.S.
FDA issues a draft guidance on how to use and submit forms FDA 3988 and 3989 for certain postmarketing studies or clinical trials.