FDA grants Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia.
The National Council on Disability says FDA and other federal agencies should have active oversight over prenatal genetic testing.
Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohns disease drug PRV-6527 showed that the therapy did not perform bett...
FDA releases the FDA-483 with three observations from an inspection at East Marietta Drug Company.
FDA denies most requests in Public Citizen and BioMedEcon petitions seeking stronger labeling and other actions for dopamine agonists.
Attorney Jeffrey Shapiro calls on FDA to stop all enforcement oversight of laboratory-developed tests until Congress specifically defines the agencys ...
FDA and FTC send a joint Warning Letter to Rooted Apothecary (Naples, Florida) for illegally selling unapproved products containing cannabidiol online...
FDA makes available a final guidance entitled Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review.