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 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 - Wednesday, January 14, 2026
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Regulatory actions for April 7, 2020

April 7, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Alnylam, Ascentage, Blaze, Immunomedics, Merck.
Read More
olympus-meditate-itind.png

FDA gives de novo nod to Itind for benign prostatic hyperplasia

April 6, 2020
By Meg Bryant
Olympus Medical Systems Group, of Center Valley, Pa., a division of Olympus Corp., is preparing the U.S. launch of the Itind device for the treatment of benign prostatic hyperplasia (BPH), following FDA de novo authorization earlier this year. The nonsurgical, minimally invasive treatment is made by Medi-Tate Ltd., of Or-Akiva, Israel.
Read More
Axonics-r-snm-11-18.jpg

Axonics looks to expand reach with its r-SNM system

April 6, 2020
By Liz Hollis
Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.
Read More

Regulatory front for April 6, 2020

April 6, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Mimedx.
Read More

Regulatory actions for April 6, 2020

April 6, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medi-Tate, Merit Medical, Olympus.
Read More

Regulatory actions for April 6, 2020

April 6, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, BMS, Daiichi, Eisai, GW, Histogen, Hope, Mallinckrodt, Mateon, Mesoblast, Novo Nordisk, Takeda, Tetra, Tracon.
Read More

Regulatory front for April 6, 2020

April 6, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Gilead.
Read More

FDA approves Reblozyl to treat anemia in MDS

April 6, 2020
Canadian flag

Ottawa recruits Canadian equipment makers in CA$2B COVID-19 battle

April 3, 2020
By David Godkin
TORONTO – Canadian Prime Minister Justin Trudeau has yet to rule out following U.S. President Donald Trump’s lead by invoking his nation's wartime Defense Procurement Act compelling manufacturers to begin making ventilators to combat COVID-19. For now, Ottawa has signed contracts or letters of intent with eight equipment makers.
Read More
Telehealth illustration

FCC doubles down on existing telehealth pilot, draws raves from advocates

April 3, 2020
By Mark McCarty
The U.S. Federal Communications Commission (FCC) has received funds for another telehealth program in less than a year. An agency statement indicates that the program “would immediately support health care providers” working to thwart the COVID-19 outbreak. This would be achieved in part by supporting purchases of devices and other items needed to provide telehealth, which the Connected Health Initiative said will help drive an overdue overhaul of health care in the U.S.
Read More
Previous 1 2 … 884 885 886 887 888 889 890 891 892 … 1332 1333 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Jan 14, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Jan. 14, 2026.
  • 3D rendering of antibody drug conjugated with cytotoxic payload

    ADCs’ breakout 2025 and their still-unfinished potential

    BioWorld
    Over the course of the year, and continuing into the latest scientific meetings, an extraordinary breadth of new antibody-drug conjugate (ADC) designs was...
  • Lung cancer illustration

    LINC01116 has prognostic value in lung cancer, study shows

    BioWorld MedTech
    Long noncoding RNAs (lncRNAs) have emerged as potential markers of disease, since they associate with proteins that regulate gene expression, translation or...
  • SERPINB1 as potential biomarker for spinocerebellar ataxia type 2

    BioWorld Science
    Researchers from Goethe-Universität and collaborators investigated novel molecular biomarker candidates for spinocerebellar ataxia type 2, a progressive...
  • 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 ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing