Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

RTTNews | vor 513 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 581 Tagen
Bank Of Japan Keeps Rate On Hold; Lifts Inflation Forecast On Rising Food Prices

Bank Of Japan Keeps Rate On Hold; Lifts Inflation Forecast On Rising Food Prices

The Bank of Japan maintained its interest rate but lifted its inflation outlook due to rising food prices, which had added expectations of an rate hike as soon as in October. The policy board unanimously decided to hold the uncollateralized overnight call rate to remain at around 0.5 percent.
RTTNews | vor 32 Minuten
Yen Rises After BoJ Rate Decision

Yen Rises After BoJ Rate Decision

The Japanese yen strengthened against other major currencies in the Asian session on Thursday, following the Bank of Japan's decision to increase its inflation forecast for the fiscal year while maintaining steady interest rates.
RTTNews | vor 44 Minuten
Yen Rises Against Majors

Yen Rises Against Majors

The Japanese yen strengthened against other major currencies in the Asian session on Thursday.
RTTNews | vor 1Std 9 Minuten
European Economic News Preview: German Inflation, Unemployment Data Due

European Economic News Preview: German Inflation, Unemployment Data Due

Flash inflation and unemployment from Germany are due on Thursday, headlining a busy day for the European economic news. At 2.00 am ET, Destatis releases Germany's ILO unemployment data and import price figures. Import prices are forecast to fall 1.6 percent on a yearly basis in June, following a 1.1 percent drop in May.
RTTNews | vor 3Std 10 Minuten