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Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol
(RTTNews) - Zevra Therapeutics, Inc. (ZVRA) announced Monday the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for arimoclomol, an investigational orally delivered, first-in-class treatment for Niemann-Pick disease type C (NPC).
In addition, the FDA has set a new Prescription Drug User Fee Act (PDUFA) action date of September 21, 2024, and has re-affirmed its intent to present the resubmission for discussion at an advisory committee meeting to be scheduled.
As part of the ongoing review, Zevra received notification from the FDA that it required more time to review the additional analyses provided by the Company in responses to recent information requests generated from the FDA's review.
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Zevra Therapeutics Says FDA Accepts Resubmission Of Arimoclomol NDA In Niemann-Pick Disease Type C
Rare disease therapeutics company Zevra Therapeutics, Inc. (ZVRA) announced Monday that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class treatment for Niemann-Pick disease type C.
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Zevra Therapeutics Resubmits Arimoclomol NDA To FDA
Zevra Therapeutics, Inc. (ZVRA) announced Wednesday it resubmitted its New Drug Application (NDA) for arimoclomol to the U.S. Food and Drug Administration (FDA) on December 22, 2023. Arimoclomol is an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC).
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The Canadian market got off to a weak start Friday morning and slipped deeper into the red subsequently, as U.S. President Donald Trump's sweeping tariff announcement rendered the mood bearish.
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U.S. Construction Spending Unexpectedly Sees Further Downside In June
The Commerce Department released a report on Friday unexpectedly showing a continued decrease by U.S. construction spending in the month of June. The report said construction spending fell by 0.4 percent to an annual rate of $2.136 trillion in June after sliding by 0.5 percent to a revised rate of $2.144 trillion in May.
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U.S. Consumer Sentiment Improves Marginally Less Than Previously Estimated In July
Revised data released by the University of Michigan on Friday showed consumer sentiment in the U.S. improved marginally less than previously estimated in the month of July. The University of Michigan said its consumer sentiment index for July was downwardly revised to 61.7 from a preliminary reading of 61.8. Economists had expected the index to be upwardly revised to 62.0.
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U.S. Manufacturing Index Unexpectedly Dips To Nine-Month Low In July
Manufacturing activity in the U.S. unexpectedly contracted at a slightly faster rate in the month of July, according to a report released by the Institute for Supply Management on Friday. The ISM said its manufacturing PMI edged down to 48.0 in July after inching up to 49.0 in June with a reading below 50 indicating contraction.
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