Lilly says its mirikizumab hit primary and secondary endpoints in the LUCENT-1 ulcerative colitis Phase 3 induction study.
Federal Register notice: FDA reopens the comment period for a 6/1/2020 notice entitled Listing of Patent Information in the Orange Book; Establishment...
Federal Register notice : FDA withdraws approval of 19 NDAs from multiple applicants after they notified the agency that the drugs were no longer mark...
Federal Register notice: FDA determines that Exela Pharma Sciences Nipride RTU (sodium nitroprusside), 10mg/50mL, was not withdrawn from sale for safe...
CDRH publishes an analysis of 90 examples of ways in which real-world evidence has been used in regulatory submissions and decisions.
Four medical device stakeholders voice objections to a Trump administration HHS plan to declare some medical devices exempt from FDA 510(k) review.
FDA extends by three months its review of an AbbVie supplemental NDA for Rinvoq (upadacitinib) and its use in treating adult patients with active psor...
FDA clears a Catalyst OrthoScience 510(k) for its reverse shoulder system.