BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • 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 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 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 - Saturday, February 14, 2026
Home » Topics » Regulatory » MOHW

MOHW
MOHW RSS Feed RSS

Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 9, 2025
By Marian (YoonJee) Chu
No Comments
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
Read More
Alteogen headquarters in Daejeon, South Korea

Alteogen merges two subsidiaries, forming Alteogen Biologics

May 27, 2025
By Marian (YoonJee) Chu
No Comments
Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
Read More
Alteogen headquarters in Daejeon, South Korea

Alteogen merges two subsidiaries, forming Alteogen Biologics

May 23, 2025
By Marian (YoonJee) Chu
No Comments
Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
Read More

Apimeds Pharmaceuticals raises $13.5M from NYSE American debut

May 20, 2025
By Marian (YoonJee) Chu
No Comments
Apimeds Pharmaceuticals US Inc. (APUS), a subsidiary of Kospi-listed Inscobee Inc., said May 12 that it raised $13.5 million from its stock sale on the NYSE American exchange May 9 through an offering of 3.375 million shares at $4 per share. Hopewell, N.J.-based APUS is the second pharmaceutical company with Asian ties to float shares on the U.S. market this year.
Read More
Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 19, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Read More

Apimeds Pharmaceuticals raises $13.5M from NYSE American debut

May 14, 2025
By Marian (YoonJee) Chu
No Comments
Apimeds Pharmaceuticals US Inc. (APUS), a subsidiary of Kospi-listed Inscobee Inc., said May 12 that it raised $13.5 million from its stock sale on the NYSE American exchange May 9 through an offering of 3.375 million shares at $4 per share. Hopewell, N.J.-based APUS is the second pharmaceutical company with Asian ties to float shares on the U.S. market this year.
Read More
Koreabio Humanase KOH Sungho
Drug design, drug delivery and technologies

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 14, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Read More
Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 13, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Read More
Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 13, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Read More
Trump tariff EO signing

South Korea urges US to exempt pharma, allies from tariffs

May 13, 2025
By Marian (YoonJee) Chu
No Comments
South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.
Read More
Previous 1 2 3 4 5 6 7 8 Next

Popular Stories

  • Today's news in brief

    BioWorld
  • Illustration of SCAN in Parkinson’s vs healthy subcortex

    SCAN is core circuit affected in Parkinson’s disease

    BioWorld Science
    Parkinson’s disease (PD) is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder,...
  • 3D illustration of skin layers

    TL1A is overexpressed in hidradenitis suppurativa

    BioWorld Science
    Despite the availability of advanced therapeutic options, about 40%-50% of patients with hidradenitis suppurativa do not achieve significant improvement in...
  • Woman and 3D brain

    Astellas’ ASP-2246 shows promise in stroke management

    BioWorld Science
    Astellas Pharma Inc. recently presented data regarding ASP-2246, a drug candidate comprised of an mRNA encoding the transcription factor NeuroD1 encapsulated in...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for Feb. 10, 2026
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • 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 ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing