An attorney who works for a company regulated by FDA asks the DC federal court to stop the agency from publishing the attorneys name and identifying i...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Cipla USAs Zemdri (plazomicin).
Viking Therapeutics provides encouraging top-line data from its Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic stea...
A Minnesota federal judge enters a $487 million judgment against Cameron-Ehlen Group, which does business as Precision Lens, for violations of the Fal...
FDA approves an expanded indication for Abbott spinal cord stimulation (SCS) devices treating chronic back pain in those who have not had or are not ...
Five stakeholders comment on an FDA question-and-answer draft guidance on using electronic systems, records, and signatures in clinical investigations...
Phoenix, AZ-based Pharmedica USA tells FDA it will stop all drug production and distribution after the agency finds CGMP violations during an inspecti...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Intact Vasculars Tack Endovascular System....
