Business
Business
Latest Headlines
Top Stories
Breaking News
Earnings
Biotech
Investors
Stock Alerts
IPOs
M&A
Canadian
UK
Wallstreet Events
Industry News
Industry News
Technology
Software
Banking
Automotive
Energy
More
Corp. Calendars
Dividends
Stock Splits
Buybacks
Conference Calls
Earnings Calendar
Earnings Calendar
Pos Pre-announcements
Profit Warnings
Positive Surprise
Negative Surprise
Latest Earnings
FDA Calendars
Drug Approvals
Clinical Trial Calendar
Ratings Changes
Upgrades
Downgrades
Cov Initiations
Cov. Reiterated
Economy
Economic News
US
Europe
Asia
Global
Economic Calendar
Economic Scorecard
Cryptocurrency
Crypto
Cryptocurrency
Blockchain
Markets
Markets
Morning Mkt Analysis
US Commentary
European Commentary
Asian Commentary
Canadian Commentary
Indian Commentary
Commodities
Bonds
Currencies
Politics
Politics
US
World
White House
Elections
General News
Forex
Forex
FX Top Stories
Currency Analysis
Currency Alerts
Economic Calendar
Economic Scorecard
Health
Health
Coronavirus
COVID-19 Calendar
Diet & Fitness
Cannabis
Kids Health
Men's Health
Women's Health
Cancer News
Drug Development
Mental Health
Slide Shows
Entertainment
Entertainment
Top Stories
Music news
Pop
Rock
Classic Rock
Rap/Hip-Hop
Country
Alternative
Oldies
All Genre
Content Licensing
Content Licensing
Newswires & Feeds
Content Syndication
Digital Signage Services
Radio News Services
Premium Services
Premium
Intelligent Investor
Biotech Investor
NEW
Login
More
Latest News Videos
Free Content
RSS Feeds
Press Releases
Search
Contact Us
Business
Corp. News
Latest Headlines
Biotech
Investors
Stock Alerts
IPOs
M&A
Top Stories
Breaking News
Earnings
Canadian
UK
Wallstreet Events
Industry News
Technology
Software
Banking
Automotive
Energy
More
Corp. Calendars
Dividends
Stock Splits
Buybacks
Conference Calls
Earnings Calendar
Earnings Calendar
Pos Pre-announcements
Profit Warnings
Positive Surprise
Negative Surprise
Latest Earnings
FDA Calendars
Drug Approvals
Clinical Trial Calendar
Ratings Changes
Upgrades
Downgrades
Cov Initiations
Cov. Reiterated
Economy
US
Europe
Asia
Global
Economic Calendar
Economic Scorecard
Crypto
Cryptocurrency
Blockchain
Markets
Market News
Morning Mkt Analysis
US Commentary
European Commentary
Asian Commentary
Canadian Commentary
Indian Commentary
Commodities
Bonds
Currencies
Politics
US
World
White House
Elections
General News
Forex
FX Top Stories
Currency Analysis
Currency Alerts
Economic Calendar
Economic Scorecard
Health
Health News
Coronavirus
COVID-19 Calendar
Diet & Fitness
Cannabis
Kids Health
Men's Health
Women's Health
Cancer News
Drug Development
Mental Health
Slide Shows
Entertainment
Entertainment News
Top Stories
Music News
Pop
Rock
Classic Rock
Rap/Hip-Hop
Country
Alternative
Oldies
All Genre
Content Licensing
Newswires & Feeds
Content Syndication
Digital Signage Services
Radio News Services
Premium
Intelligent Investor
Biotech Investor
Login
More
Latest News Videos
Free Content
RSS Feeds
Press Releases
Search
Contact Us
FDA Calendar - Kura Oncology Inc.
Company Name
Kura Oncology Inc.
KURA
Drug Name
ziftomenib (NDA)
Event Name
FDA decision on ziftomenib for treatment for adult patients with relapsed or refractory acute myeloid leukemia with a nucleophosmin 1 mutation
Event Date
11/30/2025
Outcome Date
11/13/2025
Outcome
FDA approved KOMZIFTI (ziftomenib), the first and only once-daily targeted therapy for adults with relapsed or refractory NPM1-Mutated Acute Myeloid Leukaemia on Nov.13, 2025
Drug Status
Breakthrough Therapy Designation
Rival Drugs
Market Potential
Other Approvals
News
FDA Reviews Kura's NDA For Ziftomenib To Treat Acute Myeloid Leukemia With NPM1 Mutation
Return to FDA Calendar
RELATED NEWS (Kura Oncology Inc.)
Friday's After-Hours Gainers: Biotech And Genomics Stocks Show Strength
First Commercial Sale Of KOMZIFTI In U.S. Triggers $135 Million Milestone Payment To Kura
Editors Pick
ByteDance Signs Deal For TikTok's New US JV To Avoid Ban
December 19, 2025 01:16 ET
SpaceX Boosts Plans For 2026 IPO, With Upto $1.5 Trln Valuation: Reports
December 10, 2025 09:07 ET
Amazon Plans $35 Bln Investment In India By 2030 To Boost AI Innovation
December 10, 2025 04:37 ET
Trump Warns Netflix-Warner Bros. Deal 'could Be A Problem'
December 08, 2025 05:34 ET