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Calliditas Therapeutics: PDUFA goal date extension for Nefecon NDA in the U.S.

Calliditas Therapeutics: PDUFA goal date extension for Nefecon NDA in the U.S.
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

United States , Marie Galay , Exchange Commission , Approval Program , Corporate Communications , Company Nasdaq Stockholm , Drug Administration , Nasdaq Stockholm , New Drug Application , Accelerated Approval Program , Nasdaq Global Select Market , Private Securities Litigation Reform Act ,

Controversial Aduhelm Alzheimer Drug's Quick Approval To Be Reviewed: US HHS Now Questions FDA's Decision

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.

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

Neal Milner: Why The Latest Alzheimer's 'Breakthrough' May Offer False Hope
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United States , Albert Einstein , Congressional Committee , Approval Program , Alzheimer Association , Drug Administration , Central Nervous System Drugs Advisory Committee , Accelerated Approval Program , ஒன்றுபட்டது மாநிலங்களில் , ஆல்பர்ட் ஐன்ஸ்டீன் , காங்கிரஸ் குழு , ஒப்புதல் ப்ரோக்ர்யாம் , முதுமறதி சங்கம் , முடுக்கப்பட்ட ஒப்புதல் ப்ரோக்ர்யாம் ,

TRICIDIA INVESTIGATION INITIATED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Investigates the Officers and Directors of Tricida, Inc.

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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 th ....

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