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 […]
Tag: Omecamtiv Mecarbil
Cytokinetics Provides Regulatory Update for Omecamtiv Mecarbil
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 […]
Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil
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) […]