FDA approves a Zoll Medical PMA for the TherOx System, which provides supersaturated oxygen therapy to reduce heart muscle damage in certain heart att...
Battelle gains an emergency use authorization for its Critical Care Decontamination System for decontaminating respirator masks.
FDA approves an Eli Lilly supplemental BLA for Taltz (ixekizumab) injection, 80 mg/mL, for treating pediatric patients with moderate to severe plaque ...
Amid controversy over President Trumps support for the drug, FDA reverses itself to issue an emergency use authorization to permit the off-label use o...
FDA Review posts product approval summaries for the week ending 3/27/2020.
Federal Register notice: FDA seeks comments on an information collection extension related to its guidance entitled Combination Products: How to Write...
Dr. Reddys Laboratories recalls four lots of phytonadione injectable emulsion, 10 mg/mL single-dose ampules due to the potential for ampules to break ...
FDA releases a guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.