Federal Register notice: FDA seeks OMB approval for a new information collection entitled Guidance for Industry on Compounded Drug Products That Are E...
FDA and NIH officials make the case for research into biomarkers that can predict efficacy of new opioid-abuse drugs based on reducing the quantity a...
FDA grants Amgen accelerated approval for Blincyto (blinatumomab) and its expanded use to treat adults and children with B-cell precursor acute lympho...
Insmed files an NDA for Alis (amikacin liposome inhalation suspension), indicated for treating adult patients with nontuberculous mycobacterial lung d...
The HHS Inspector General says FDA should educate drug dispensers about their responsibilities under the Drug Supply Chain Security Act.
Three industry stakeholders praise an FDA draft guidance on IVDs and suggest changes.
FDA approves a Hologic PMA for its Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology and their use on the companys 3Dimensio...
FDA accepts for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating certain adu...