• 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

Anaconda Funnel Catheter in vessel

Anaconda Biomed funnel catheter gets EU nod for ischemic stroke

July 1, 2025
By Shani Alexander
Anaconda Biomed SL recently received CE mark for the Ana5 funnel catheter, designed to improve mechanical thrombectomy in the treatment of acute ischemic stroke. The company hopes that the device, which has a vessel-matching diameter funnel to maximize the capture of blood clots, could be the holy grail in mechanical thrombectomy.
Read More
Handshake with charts, maps, data

US agencies to assemble health care fraud data fusion system

July 1, 2025
By Mark McCarty
The U.S. Department of Justice reported June 30 that several hundred defendants were charged with health care fraud of more than $14 billion, but the more important news may be that federal agencies are standing up a data sharing system that will make this kind of enforcement more effective.
Read More
CAR T cell attacking cancer cells

China’s NMPA accepts Carsgen’s NDA for Claudin18.2-targeted CAR T

July 1, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
Read More
Judge's gavel with US flag

Another court orders halt to US HHS reorganization

July 1, 2025
By Mari Serebrov
No Comments
Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.
Read More

ACIP questions remain unanswered

July 1, 2025
By Mari Serebrov
No Comments
While the first meeting of the U.S. CDC’s newly minted Advisory Committee for Immunization Practices (ACIP) is now recent history, questions about the makeup of the committee and its future direction remain unanswered.
Read More
Hong Kong Department of Health director and assistant directors

Hong Kong to set up CMPR as medical products authority by 2026

July 1, 2025
By Marian (YoonJee) Chu
No Comments
Hong Kong’s Department of Health (DH) announced plans to establish a new medical products regulatory agency called the Hong Kong Centre for Medical Products Regulation (CMPR) by the end of 2026.
Read More
DNA and cancer cells
Cancer

Hemispherian’s GLIX-1 awarded US orphan drug designation for malignant glioma

July 1, 2025
No Comments
GLIX-1 is a first-in-class small-molecule therapeutic targeting DNA repair vulnerabilities in cancer cells.
Read More
tissium

Tissium’s polymer solution set to transform nerve repair after FDA nod

June 30, 2025
By Shani Alexander
Could the U.S. FDA’s de novo marketing authorization for Tissium SA’s Coaptium Connect, an atraumatic sutureless solution for peripheral nerve repair, signal a transformative shift away from sutures in nerve surgery? Only time will tell.
Read More
Cyber security padlock

FDA retains non-statutory definition of cyber device in final guidance

June 30, 2025
By Mark McCarty
The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.
Read More
Hourglass on glowing circuit board, symbolizing time and technology

UK’s MHRA first regulatory to join Health AI’s global regulator network

June 30, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 1268 1269 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 3, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 2, 2025.
  • AI-generated illustration of CAR T cells

    Researchers arm CAR T cells to fight solid tumors

    BioWorld
    Aussie researchers have used CRISPR gene editing tools to “armor” chimeric antigen receptor (CAR) T cells to activate additional cancer-fighting proteins at the...
  • Digital lungs illustration

    Bioversys, Shionogi in CHF529M lung infection collaboration

    BioWorld Science
    Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on...
  • Medtronic Vitalflow ECMO

    Medtronic receives CE mark for its Vitalflow ECMO system

    BioWorld MedTech
    Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in...
  • 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