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...
FDA clears an Exactech 510(k) for the Equinoxe Stemless Shoulder, a bone conserving and canal sparing prosthesis that is compatible with the Equinoxe ...
The Securities and Exchange Commission charges Silicon Valley-based Theranos, its founder and CEO Elizabeth Holmes, and former president Ramesh Balwan...
The House of Representatives fails to pass HR 5247, the Right to Try Act of 2018, under suspension of the rules.
FDA warns Frances Quali-Controle contract laboratory about CGMP violations in producing finished pharmaceuticals.