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Lilly says its mirikizumab hit primary and secondary endpoints in the LUCENT-1 ulcerative colitis Phase 3 induction study.[ Price : $8.95]
Federal Register notice: FDA reopens the comment period for a 6/1/2020 notice entitled Listing of Patent Information in the Orange...[ Price : $8.95]
Federal Register notice : FDA withdraws approval of 19 NDAs from multiple applicants after they notified the agency that the drugs...[ Price : $8.95]
Federal Register notice: FDA determines that Exela Pharma Sciences Nipride RTU (sodium nitroprusside), 10mg/50mL, was not withdraw...[ Price : $8.95]
CDRH publishes an analysis of 90 examples of ways in which real-world evidence has been used in regulatory submissions and decisio...[ Price : $8.95]
Four medical device stakeholders voice objections to a Trump administration HHS plan to declare some medical devices exempt from F...[ Price : $8.95]
FDA extends by three months its review of an AbbVie supplemental NDA for Rinvoq (upadacitinib) and its use in treating adult patie...[ Price : $8.95]
FDA clears a Catalyst OrthoScience 510(k) for its reverse shoulder system.