Federal Register notice: FDA issues a final order to reclassify surgical staplers for internal use from Class 1 into Class 2 and subject to premarket ...
FDA outlines a new pilot program on using novel excipients with the intent to increase their use in drug development, especially if they have potentia...
Janssen Pharmaceutical files a supplemental BLA for Stelara (ustekinumab) for treating pediatric patients aged five years and older with juvenile psor...
FDA grants Genentech a breakthrough therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration in A...
FDA issues a warning to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and...
Federal Register notice: FDA announces a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting.
Federal Register notice: FDA releases a revised draft guidance entitled Hospital and Health System Compounding Under Section 503A of the Federal Food,...
FDA says the Imperative Care recall of specific lots of its ZOOM 71 reperfusion catheter is Class 1.