Federal Register notice: FDA withdraws the approval of an Emergent Biosolutions supplemental NDA for Narcan (naloxone hydrochloride 2 mg/.1 ml) after ...
An HHS Covid-19 Public Health Emergency Transition Roadmap outlines FDAs flexibilities and actions that will not be affected after the health emergenc...
FDA issues two complete response letters to Phathom Pharmaceuticals one for an NDA for vonoprazan for treating erosive esophagitis, and the other for...
Ropes & Gray attorneys explain the impact of the upcoming termination of the Covid-19 public health emergency on FDA guidances and policies.
FDA says the GE Healthcare 12/19/22 recall of nuclear medicine systems is Class 1.
Bloomberg reports that experts are debating the value of therapeutics like Eigers lambda peginterferon against Covid.
FDA approves Regeneron Pharmaceuticals Eylea (aflibercept) injection to treat preterm infants with retinopathy of prematurity.
FDA updates an ongoing safety communication on Philips Respironics ventilators, BiPAP machines, and CPAP machines to provide information about medical...