• 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
  • Index insights
  • 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
    • Index insights
  • 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

New MEK inhibitor approval delivers first NF1 therapy, PRV for Astrazeneca

April 13, 2020
By Michael Fitzhugh
Following a priority review, partners Astrazeneca plc and Merck & Co. Inc. have gained a green light from the FDA for U.S. marketing of the oral MEK1/2 inhibitor Koselugo (selumetinib), the first FDA-approved treatment for the rare genetic disorder neurofibromatosis type 1 (NF1).
Read More

Regulatory actions for April 13, 2020

April 13, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch Therapeutics, Cytosorbents.
Read More

Regulatory front for April 13, 2020

April 13, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More

Regulatory actions for April 13, 2020

April 13, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Arch, Arcturus, Ascletis, Astrazeneca, Athersys, Beigene, Can-Fite, Fennec, Hope, Merck, Predictive Biotech, Proteostasis, Ridgeback.
Read More

Regulatory actions for April 10, 2020

April 10, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Marker Therapeutics, Steris, Terumo.
Read More

Regulatory front for April 10, 2020

April 10, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Marker Therapeutics, Steris, Terumo.
Read More

Regulatory front for April 10, 2020

April 10, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More
DNA illustration

DNA Electronics earns breakthrough device designation for Lidia-seq

April 9, 2020
By Nuala Moran
LONDON – DNA Electronics Ltd. (DNAe) won a U.S. FDA breakthrough device designation for its semiconductor-based DNA sequencing technology Lidia-seq and for the first assay based on the platform, which will detect bloodstream infections and antimicrobial resistance (AMR) genes at point of care.
Read More

FDA posts OUS device warnings as U.S. company receives second warning in three years

April 9, 2020
By Mark McCarty
The FDA’s device center has resumed a more normal pace of warning letter issuance in recent months, and the latest batch posted to the warning letter website features warning letters to one device maker in Europe and three firms in Asia. One U.S. firm, Steiner Biotechnology LLC, of Henderson, Nev., also received a warning, however, which is the second the company has received since June 2017.
Read More

Vapotherm’s Oxygen Assist Module wins FDA breakthrough device nod

April 9, 2020
By Meg Bryant
The U.S. FDA has granted breakthrough device designation to Vapotherm Inc. for its Oxygen Assist Module (OAM), for use with its Precision Flow assistive breathing systems. The new module is designed to aid clinicians in maintaining a targeted blood oxygen range in patients requiring oxygen therapy.
Read More
Previous 1 2 … 815 816 817 818 819 820 821 822 823 … 1266 1267 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 27, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 27, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 24, 2025
  • BIO2025: John Crowley and Martin Makary

    BIO 2025: Makary lays out FDA’s path, launches pilot review program

    BioWorld
    On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the...
  • Andembry

    New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

    BioWorld
    Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa...
  • 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
    • 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

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • 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