• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • 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
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • 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
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Topics » Regulatory » IND

IND
IND RSS Feed RSS

Nervous system illustration
Neurology/psychiatric

Sineugene’s TRIM72-targeted gene therapy for ALS gains IND clearance from FDA

March 25, 2025
Sineugene Therapeutics Co. Ltd. has obtained IND clearance from the FDA for SNUG-01, a first-in-class tripartite motif protein 72 (TRIM72)-targeted gene therapy candidate for amyotrophic lateral sclerosis (ALS). A phase I/IIa trial will evaluate SNUG-01 in adults with ALS.
Read More
mRNA on digital background
Immuno-oncology

Everest Medicines’ mRNA cancer vaccine EVM-14 gains IND clearance

March 24, 2025
Everest Medicines Ltd. has obtained IND clearance from the FDA for EVM-14, an off-the-shelf mRNA cancer vaccine targeting multiple tumor-associated antigens and designed to treat various cancers, including non-small-cell lung cancer and head and neck cancer.
Read More
3D rendering of skin cells and elastin with collagen layer
Dermatologic

Sagimet’s FASN inhibitor cleared to enter clinic for acne

March 12, 2025
Sagimet Biosciences Inc. has obtained IND clearance from the FDA for TVB-3567 (ASC-60), a selective small-molecule fatty acid synthase (FASN) inhibitor set to enter clinical development for the treatment of acne. A first-in-human phase I trial of TVB-3567 in individuals with or without acne is expected to begin this year.
Read More
Cancer

Mindrank’s dual WEE1 and YES1 kinase inhibitor cleared to enter clinic in US

March 10, 2025
Mindrank Ltd. has announced that the FDA has cleared the company’s IND application for MRANK-106, a potentially first-in-class, orally available dual inhibitor of WEE1 and YES1 kinases, for the treatment of pancreatic cancer, small-cell lung cancer, ovarian cancer, breast cancer and colorectal cancer.
Read More
3D illustration demonstrating CAR T therapy
Immuno-oncology

Bioheng Therapeutics’ CD7-targeted universal CAR T-cell therapy gains IND clearance

March 5, 2025
Bioheng Therapeutics US LLC has obtained IND approval from the FDA for CTD-402, a CD7-targeted universal CAR T-cell therapy, for the treatment of pediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma.
Read More
Illustration of tumor
Immuno-oncology

Fapon’s immunocytokine FP-008 gains IND clearance for solid tumors

March 4, 2025
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
Read More
Illustration of tumor
Immuno-oncology

Fapon’s immunocytokine FP-008 gains IND clearance for solid tumors

Feb. 28, 2025
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
Read More
Globe showing Asia-Pacific region

Asia recap: Innocare, Akeso in phase III; Deepseek in Antengene

Feb. 25, 2025
By Marian (YoonJee) Chu
Several Asia biotechs this week – including Innocare Pharma Ltd., Akeso Pharmaceuticals Inc., Sanbio Co. Ltd. and Ascletis Pharma Inc. – unveiled the start of new late-stage clinical trials or interim findings from early stage studies.
Read More
3D illustration demonstrating antibody-drug conjugate.

Radiance wins ROR1 ADC rights from CSPC in potential $1B+ deal

Feb. 25, 2025
By Marian (YoonJee) Chu
Radiance Biopharma Inc. bought its way into the ROR1 antibody-drug conjugate (ADC) space through a potential $1 billion-plus licensing deal, including a $15 million up-front payment, with CSPC Megalith Biopharmaceutical Co. Ltd. for rights to RB-164 (SYS-6005) in the U.S. and select countries.
Read More
Globe showing Asia-Pacific region

Asia recap: Innocare, Akeso in phase III; Deepseek in Antengene

Feb. 21, 2025
By Marian (YoonJee) Chu
Several Asia biotechs this week – including Innocare Pharma Ltd., Akeso Pharmaceuticals Inc., Sanbio Co. Ltd. and Ascletis Pharma Inc. – unveiled the start of new late-stage clinical trials or interim findings from early stage studies.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 41 42 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 6, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 6, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 3, 2025
  • Biotech deal illustration

    City hits the town with $1B-plus deal with Biogen

    BioWorld
    A development deal with Biogen Inc. could eventually bring City Therapeutics Inc. about $1 billion in milestone payments. It’s a step in the direction the company...
  • Cancer cell in the cross-hairs

    Pan-cancer proteome atlas reveals new biomarkers and targets

    BioWorld Science
    An international group of scientists has completed the first draft of The Pan-Cancer Proteome Atlas (TPCPA). The project is based on mass spectrometry of 22...
  • 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
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • 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

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • 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
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe