• 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

Regulatory
Regulatory RSS Feed RSS

Australia flag with microscope, test tubes

Australia looks to Asia as Trump administration threatens funding

April 1, 2025
By Tamra Sami
Australia’s top universities are looking more to Asia for research collaborations following threats from the Trump administration to stop funding research at institutions that don’t comply with U.S. narratives.
Read More
Illustration of lung cancer, DNA double helix

FDA clears Gleamer, Azmed AI-powered tools for chest X-rays

April 1, 2025
By Shani Alexander
Two French startups, Gleamer SAS and Azmed SAS, received clearance from the U.S. FDA for their AI-powered tools for chest X-rays. They join an increasing number of companies developing software tools to help clinicians detect a range of abnormalities on images, enhancing diagnostic accuracy, reducing delays and improving patient outcomes.
Read More
AI-generated illustration of DNA double helix

FTC eyeing 23andme’s disposition of genomic data

April 1, 2025
By Mark McCarty
The financial collapse of direct-to-consumer genetic testing pioneer 23andme Holding Co. is already one of the more notable developments of 2025, but the company’s customers have less to worry about with regard to their data.
Read More
U.S. flag on columned building

FDA’s loss in lawsuit opens door to LDT promotion

April 1, 2025
By Mark McCarty
The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.
Read More
Doctor with illustration of kidneys

Otsuka submits first BLA to FDA for sibeprenlimab in IgAN

April 1, 2025
By Tamra Sami
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
Read More

Anocca launching Europe study of gene-edited T-cell therapy

April 1, 2025
By Nuala Moran
Anocca AB has secured the first regulatory authorization in Europe for a CRISPR-Cas gene-edited T-cell receptor T-cell therapy trial, with the phase I/II study now due to start over the next three months at sites in Sweden, Germany, Denmark and the Netherlands.
Read More
HHS Secretary Robert Kennedy

Where’s the ‘radical transparency’ Kennedy promised?

April 1, 2025
By Mari Serebrov
As the U.S. Department of Health and Human Services begins implementing its reorganization and reduction-in-force plan by sending out termination notices this week to 10,000 more employees across its agencies, top Democrats in Congress are demanding details about the plan.
Read More
Australia flag with microscope, test tubes

TGA feeling the Brussels effect in IVD risk classification draft

March 31, 2025
By Mark McCarty
Australia’s Therapeutic Goods Administration floated a draft rule on risk classification for in vitro diagnostics, which does not apply to home use tests, the subject of impending rulemaking.
Read More
Illustration of hole in vessel wall with repair process in progress

Sanofi adds to hemophilia arsenal with FDA nod for Qfitlia

March 31, 2025
By Jennifer Boggs
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors.
Read More

Pep-Therapy advancing orphan drug PEP-010 in pancreatic cancer

March 31, 2025
By Nuala Moran
French biotech Pep-Therapy SAS is in the midst of raising a €20 million (US$21.62 million) round and, at the same time, prospecting for potential partners after winning FDA orphan drug designation for its bifunctional peptide Pep-010 in the treatment of pancreatic cancer. Pep-010 currently is moving to the conclusion of a phase Ib trial and the new money will fund phase II development.
Read More
Previous 1 2 … 23 24 25 26 27 28 29 30 31 … 1259 1260 Next

Popular Stories

  • Today's news in brief

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

    BioWorld MedTech
    BioWorld MedTech briefs for June 9, 2025.
  • Red blood cells in an artery with cholesterol

    In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

    BioWorld
    In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant...
  • Neuronata-R

    Corestemchemon preps US BLA filing for stem cell ALS therapy

    BioWorld
    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...
  • The Nasdaq Stock Exchange headquarters in New York

    Omada, Caris arrivals continue med-tech IPO hot streak

    BioWorld MedTech
    Omada Health Inc. rang the opening bell on the New York Stock Exchange on June 6, marking its first day as a public company, but it won’t be the most recent IPO...
  • 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