Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

RTTNews | hace 507
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.

read more
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 | hace 575
Japan Inflation Data Due On Friday

Japan Inflation Data Due On Friday

Japan will on Friday release July figures for Tokyo inflation, highlighting a light day for Asia-Pacific economic activity. In June, both overall and core CPI were up 3.1 percent on year.
RTTNews | hace 59 minutos
Euro Higher Against Majors

Euro Higher Against Majors

The euro climbed against its major counterparts in the New York session on Thursday, as upbeat earnings from Google parent Alphabet lifted tech shares.
RTTNews | hace 2h 25min
Swiss Market Ends Modestly Lower

Swiss Market Ends Modestly Lower

The Switzerland market stayed a bit positive in early trades on Thursday, but retreated around mid morning and then spent the rest of the day's session in negative territory, as investors stayed largely cautious, reacting to earnings and awaiting news from the trade front.
RTTNews | hace 5h 28min
European Stocks Close Broadly Higher

European Stocks Close Broadly Higher

European stocks closed broadly higher on Thursday despite paring most of their early gains, after the European Central Bank left its interest rate unchanged for the first time in a year. The ECB held its key interest rates steady, in line with expectations.
RTTNews | hace 5h 48min
U.S. New Home Sales Rebound Much Less Than Expected In June

U.S. New Home Sales Rebound Much Less Than Expected In June

After reporting a steep drop by new home sales in the U.S. in the previous month, the Commerce Department released a report on Thursday showing a modest rebound by new home sales in the month of June. The Commerce Department said new home sales rose by 0.6 percent to an annual rate of 627,000 in June after plummeting by 11.6 percent to a rate of 623,000 in May.
RTTNews | hace 7h 40min
U.S. Initial Jobless Claims Unexpectedly Dip To 217,000

U.S. Initial Jobless Claims Unexpectedly Dip To 217,000

The Labor Department released a report on Thursday unexpectedly showing another modest decrease by first-time claims for U.S. unemployment benefits in the week ended July 19th. The report said initial jobless claims edged down to 217,000, a decrease of 4,000 from the previous week's unrevised level of 221,000. Economists had expected jobless claims to rise to 227,000.
RTTNews | hace 8h 22min