FDA warns Opternative that it is distributing a mobile medical device app without agency approval.
Federal Register correction notice: FDA corrects a final order entitled Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syn...
Federal Register notice: FDA withdraws approval of four Sun Pharmaceutical ANDAs because the drug products are no longer marketed.
Two Hyman, Phelps & McNamara attorneys say the Supreme Court is considering whether to hear Gileads challenge of a 9th Circuit Appeals Court ruling on...
Federal Register notice: FDA announces a 4/17 public meeting entitled Patient-Focused Drug Development on Opioid Use Disorder.
FDA says Biogen and AbbVie are pulling their Zinbryta multiple sclerosis drug from the market worldwide due to concerns about its risks.
FDA accepts for review a Merz North America supplemental BLA for Xeomin (incobotulinumtoxinA) for treating chronic sialorrhea (excessive drooling) due...
Washington Legal Foundation says the 3rd Circuit Court of Appeals followed FDA reasoning in holding that a medical device state law suit was preempted...