The Latest Cardiac and Vascular News
Complete Response Letter States that GALACTIC-HF Alone Does not Establish Substantial Evidence of Effectiveness Sufficient for Approval Company Expects to Request Meeting with FDA to Discuss Potential Next Steps Cytokinetics to Host Conference Call and Webcast on March 1, 2023 at 8:30 am Eastern Time SOUTH SAN FRANCISCO, Calif., Feb. 28, […]
Recent Company Submission in Response to FDA Request Extends PDUFA Date SOUTH SAN FRANCISCO, Calif., June 17, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that, in response to a request from the U.S. Food and Drug Administration (FDA), the company recently provided additional pharmacokinetic analyses of omecamtiv mecarbil related […]
FDA Plans to Convene Advisory Committee Meeting SOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the Company recently participated in a mid-cycle communication meeting with the U.S. Food & Drug Administration (FDA) and was informed that the Agency plans to convene an […]
