BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Tuesday, December 9, 2025
See today's BioWorld Asia
Home » Nothing flashy: FDA approves Astellas’ menopause drug
To read the full story, subscribe or sign in.

Nothing flashy: FDA approves Astellas’ menopause drug

May 16, 2023
By Lee Landenberger
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
BioWorld Asia Regulatory Genitourinary/sexual function Women's health Japan U.S. FDA

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 9, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Dec. 9, 2025.
  • Red dollar sign under microscope

    Medline plans record-setting $5.37B IPO

    BioWorld MedTech
    Almost a year since first filing its S-1 to return to public markets, Medline Inc. revealed the price range for the most awaited IPO of 2025. The massive medical...
  • Multiple myeloma illustration

    ASH 2025: Tec-dara shines on ‘functional cure’ Majestec-3 MM data

    BioWorld
    Impressive results of a potential second-line combination treatment for multiple myeloma from the Majestec-3 trial of teclistamab plus daratumumab raised eyebrows...
  • 3D rendering of prion structure

    Epigenetic technology could eliminate misfolded prion proteins

    BioWorld Science
    The number of deaths caused by prion diseases reaches about 30,000 annually. Only 5 months pass from the diagnosis of seemingly healthy patients to the fatal...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • NME Digest
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing