Page 16 - Accelerated Approval Program News Today : Breaking News, Live Updates & Top Stories | Vimarsana
Calliditas Therapeutics: PDUFA goal date extension for Nefecon NDA in the U S
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Controversial Aduhelm Alzheimer Drug s Quick Approval To Be Reviewed: US HHS Now Questions FDA s Decision
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Biogen Inc : An open letter to the Alzheimer s disease community from our Head of Research and Development, Alfred Sandrock, M D , Ph D
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Neal Milner: Why The Latest Alzheimer s Breakthrough May Offer False Hope
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NEW ORLEANS, May 7, 2021 /PRNewswire/ Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC ( KSF ), announces that KSF has commenced an investigation into Tricida, Inc. (NasdaqGS: TCDA).
On July 15, 2020, the Company disclosed that it received a notification from the U.S. Food and Drug Administration (FDA) regarding its ongoing review of the Company s New Drug Application (NDA) for its drug candidate, veverimer (TRC101) wherein the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. Then, on October 29, 2020, the Company announced an update on its End-of-Review Type A meeting with the FDA regarding the veverimer NDA, and now believes the FDA will also require evidence of veverimer s effect on CKD progression from a near-term interim analysis of the VALOR-CKD trial for approval under the Accelerate