Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

RTTNews | vor 505 Tagen
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 Resubmits Arimoclomol NDA To FDA

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).
RTTNews | vor 573 Tagen
NZ Dollar Slides Against Majors

NZ Dollar Slides Against Majors

The New Zealand dollar weakened against other major currencies in the European session on Tuesday.
RTTNews | vor 25 Minuten
RBA Board Says Another Rate Cut Inconsistent With Cautious Stance, Minutes Show

RBA Board Says Another Rate Cut Inconsistent With Cautious Stance, Minutes Show

Reserve Bank of Australia's policymakers said cutting the interest rate for a third straight time within the gap of four meetings would be inconsistent with the cautious monetary policy stance, the minutes of the July monetary policy meeting showed Tuesday. Majority of members said that it would be prudent to wait for confirmation that inflation would sustainably return to target as forecast.
RTTNews | vor 1Std 30 Minuten
Pound Falls Against Most Majors

Pound Falls Against Most Majors

The British pound weakened against most major currencies in the European session on Tuesday.
RTTNews | vor 1Std 38 Minuten