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Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma
23 Oct 2025 20:26 GMT
… US Food and Drug Administration (FDA) has approved … FDA, Blenrep is available through a new, streamlined Risk Evaluation and Mitigation Strategy … gov. National Library of Medicine (US). Identifier NCT06679101, … in Clinical Practice. Pharmaceut Med. 2022 Jun; …
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Shareholders of Cytokinetics, Incorporated Should Contact Levi & Korsinsky Before November 17, 2025 to Discuss Your Rights – CYTK
23 Oct 2025 20:18 GMT
… the timeline for the New Drug Application (“NDA”) submission … U.S. Food and Drug Administration (“FDA”) for its NDA … s failure to submit a Risk Evaluation and Mitigation Strategy (“REMS”) that could … -NDA meetings with the FDA discussing safety monitoring and …
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Deadline Alert: Cytokinetics, Incorporated (CYTK) Shareholders Who Lost Money Urged To Contact Glancy Prongay & Murray LLP About Securities Fraud Lawsuit
23 Oct 2025 17:04 GMT
… FDA has extended the review period for its cardiac myosin inhibitor drug … required to review newly submitted Risk Evaluation and Mitigation Strategy (REMS). The Company further … initial NDA submission, despite prior FDA discussions about safety and risk …
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CYTK INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that Cytokinetics, Incorporated Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
23 Oct 2025 16:00 GMT
… the timeline for its New Drug Application (“NDA”) submission and approval … aficamten; (2) Defendants stated that FDA approval was expected in the … the absence of a required Risk Evaluation and Mitigation Strategy (“REMS”), which could delay the …
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CYTK Investors Have Opportunity to Lead Cytokinetics, Incorporated Securities Fraud Lawsuit with the Schall Law Firm
23 Oct 2025 12:49 GMT
… to believe that it expected FDA approval on its NDA for … to submit a Risk Evaluation and Mitigation Strategy (“REMS”), which could delay the FDA’s processing … pre-NDA meetings with the FDA about safety and mitigation of …
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Cytokinetics Shareholder Alert: ClaimsFiler Reminds Investors With Losses In Excess Of $100,000 Of Lead Plaintiff Deadline In Class Action Lawsuits Against Cytokinetics, Incorporated - CYTK
23 Oct 2025 01:31 GMT
… U.S. Food and Drug Administration (“FDA”) had decided not … the Company’s New Drug Application (“NDA”) for … NDA meetings with the FDA discussing safety monitoring and … the NDA without a Risk Evaluation and Mitigation Strategy, instead relying on labeling …
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ROSEN, NATIONAL TRIAL COUNSEL, Encourages Cytokinetics, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – CYTK
23 Oct 2025 01:32 GMT
… timeline for the New Drug Application (“NDA”) submission … .S. Food and Drug Administration (“FDA”) for its NDA … September 26, 2025 Prescription Drug User Fee Act (“PDUFA”) … failure to submit a Risk Evaluation and Mitigation Strategy (“REMS”) that could delay …
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CYTK Investors Should Contact Robbins LLP Regarding the Upcoming Lead Plaintiff Deadline in the Cytokinetics, Inc. Class Action
23 Oct 2025 00:48 GMT
… investors about its new drug application submission. For more … the timeline for the New Drug Application (“NDA”) submission … U.S. Food and Drug Administration for its NDA … failure to submit a Risk Evaluation and Mitigation Strategy that could delay the …
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Cytokinetics, Incorporated Securities Fraud Class Action Lawsuit Pending: Contact The Gross Law Firm Before November 17, 2025 to Discuss Your Rights – CYTK
22 Oct 2025 20:01 GMT
… the timeline for the New Drug Application (“NDA”) submission … U.S. Food and Drug Administration (“FDA”) for its NDA … s failure to submit a Risk Evaluation and Mitigation Strategy (“REMS”) that could … -NDA meetings with the FDA discussing safety monitoring and …
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Cytokinetics Shareholder Alert By Former Louisiana Attorney General: Kahn Swick & Foti, LLC Reminds Investors with Losses in Excess of $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against Cytokinetics, Incorporated - CYTK
22 Oct 2025 01:21 GMT
… U.S. Food and Drug Administration (“FDA”) had decided not … the Company’s New Drug Application (“NDA”) for … NDA meetings with the FDA discussing safety monitoring and … the NDA without a Risk Evaluation and Mitigation Strategy, instead relying on labeling …
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