• 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
  • Coronavirus
  • More reports can be found here

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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

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

Regulatory
Regulatory RSS Feed RSS

Regulatory actions for June 7, 2023

June 7, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Teleflex.
Read More

FDA warning letters hint that med-tech compliance programs drifted during COVID

June 7, 2023
By Mark McCarty
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
Read More
Map of Europe, France filled in with French flag

Committee set up in France to assess diagnostic, prognostic and predictive technology

June 7, 2023
By Bernard Banga
The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.
Read More
Smartphone displaying Stethophone app

Sparrow’s smartphone stethoscope gets FDA nod

June 7, 2023
By Meg Bryant
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
Read More

Regulatory actions for June 7, 2023

June 7, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amphera, Brainstorm, Fennec, GSK, Merck & Co., Quralis, Tscan, Vyluma.
Read More

ASCO 2023: Accelerated approvals are both hero and obstacle

June 7, 2023
By Lee Landenberger
Since accelerated approvals first began to be granted in 1992, their pace for cancer indications has increased dramatically but a revolution in science has made it tough for the U.S. FDA to find its balance.
Read More
Gavel and First Amendment

Citing US constitutional violations, Merck the first to challenge the IRA

June 7, 2023
By Mari Serebrov
The question wasn’t if, but when and how, someone would challenge the Medicare negotiation provision laid out in the Inflation Reduction Act (IRA) that was signed into U.S. law last year.
Read More

Regulatory actions for June 6, 2023

June 6, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medical Solutions, Artelon, Avatar Medical, Deepx Diagnostics.
Read More

Canbridge obtains first approval for Alagille syndrome in China

June 6, 2023
By Doris Yu
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
Read More

Canbridge obtains first approval for Alagille syndrome in China

June 6, 2023
By Doris Yu
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
Read More
Previous 1 2 … 286 287 288 289 290 291 292 293 294 … 1268 1269 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 2, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 2, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 1, 2025
  • Illustration of the β2-adrenergic receptor

    Exercise-mimicking compound offers alternative to GLP-1 therapies

    BioWorld
    An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR)...
  • Drug vials

    Industry could feel fallout of Pfizer vaccine scrutiny

    BioWorld
    In subpoenaing a former Pfizer Inc. official to appear before the U.S. House Judiciary Committee July 22, Judiciary Chair Jim Jordan, R-Ohio, signaled legislative...
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe