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 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Tuesday, December 9, 2025
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Keytruda plus Lenvima gains FDA approval for advanced endometrial carcinoma

Sep. 18, 2019

FDA approves Erleada for metastatic castration-sensitive prostate cancer

Sep. 18, 2019

Stakeholders resistant to participation mandate in radiation oncology APM

Sep. 18, 2019
By Mark McCarty
The Medicare radiation oncology alternative payment model is yet another attempt to control Medicare spending growth, but provider groups and device makers oppose mandatory program participation. Varian Medical offered a blistering critique of the participation mandate, stating that the participation mandate suggests that the U.S. Centers for Medicare and Medicaid Services (CMS) is less interested in a valid test of the program than it is in generating immediate savings.
Read More

Regulatory front

Sep. 18, 2019

Product regulatory actions for Sept. 17, 2019

Sep. 18, 2019

Dreamed wins U.S. and EU approval for AI-based insulin recommendation technology

Sep. 18, 2019
By David Ho
HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).
Read More

Regulatory front

Sep. 17, 2019

Product regulatory actions for Sept. 16, 2019

Sep. 17, 2019

Gala Therapeutics gets breakthrough device designation for Rheox system

Sep. 17, 2019
By Liz Hollis
Chronic bronchitis affects more than 9 million people in the U.S., but current treatments fail to address the overproduction of mucus. Gala Therapeutics Inc., of Menlo Park, Calif., is looking to change that.
Read More

Australia proposes revising device essential principles to align with international practices

Sep. 17, 2019
By Tamra Sami
PERTH, Australia – The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal that to change Australia's medical device essential principles for safety and performance to more closely mirror the new EU Medical Device Regulation (EU MDR).
Read More
Previous 1 2 … 937 938 939 940 941 942 943 944 945 … 1318 1319 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 8, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Dec. 8, 2025.
  • Mesothelin is biomarker, potential target in arthritic bone damage

    BioWorld Science
    In a recent study published in Cell Reports Medicine, researchers from the Institute of Chinese Materia Medica of the China Academy of Chinese Medical Sciences...
  • 3D rendering of prion structure

    Epigenetic technology could eliminate misfolded prion proteins

    BioWorld Science
    The number of deaths caused by prion diseases reaches about 30,000 annually. Only 5 months pass from the diagnosis of seemingly healthy patients to the fatal...
  • Novo Nordisk semaglutide pill

    CTAD 2025: Diagnosing semaglutide’s failure in Alzheimer’s trials

    BioWorld
    A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow cognition decline in patients with...
  • 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 ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing