BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Med-tech outlook 2026
    • 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, April 22, 2026
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Costa Rican flag, economy/growth puzzle pieces

Costa Rica leads Central America in med-tech production, exports

April 2, 2021
By Sergio Held
CAJICA, Colombia – The tiny Central American country of Costa Rica continues to cement its position as Latin America’s med-tech powerhouse after experiencing double-digit growth in exports in the first two months of the year, according to data released by Procomer, the country's exports promotion agency. “These numbers become more relevant when detailing that medical devices and precision equipment represent, for the third consecutive year, the country's main export, which had double-digit growth of 23%, thus representing 36% of the exports of the country,” the Costa Rican government said.
Read More

Investigation continues, but no evidence to restrict Astrazeneca COVID-19 vaccine use: MHRA

April 2, 2021
By Nuala Moran
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
Read More

Regulatory actions for April 2, 2021

April 2, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nano-X Imaging, Quidel.
Read More

Regulatory front for April 2, 2021

April 2, 2021
By Meg Bryant
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Infections associated with reprocessed urological endoscopes under investigation.
Read More
U.K. flag and capsules

MHRA publishes guidance on newly launched streamlined approval pathway

April 2, 2021
LONDON – A new route to the approval of drugs promises to smooth the path from clinical trials to approval, reimbursement and commissioning in the National Health Service, through closer and earlier collaboration between the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment bodies.
Read More

Regulatory actions for April 2, 2021

April 2, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Jemincare, Kite, Moderna, Ose, Regeneron, Tetra.
Read More
Pancreas illustration

Bluestar Genomics gets breakthrough nod for pancreatic cancer screening test

April 1, 2021
By Meg Bryant
Pancreatic cancer is the third leading cause of cancer death in the U.S., in part because many cases aren’t diagnosed until they are advanced. Bluestar Genomics Inc. wants to change that with its epigenomics technology which can detect early pancreatic cancer from a standard blood draw by analyzing cell-free DNA in plasma. Now, the FDA has provided a bump, granting breakthrough device designation to Bluestar’s noninvasive pancreatic cancer detection test in patients with new-onset diabetes. According to the San Diego-based startup, of an estimated 60,000 patients diagnosed with pancreatic cancer in the U.S., nearly a fourth are found to have new-onset diabetes prior to receiving their cancer diagnosis.
Read More

Regulatory front for April 1, 2021

April 1, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDIC accepting applications for the ASC pilot study.
Read More

Regulatory actions for April 1, 2021

April 1, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Becton Dickinson, Bluestar Genomics, Inspire.
Read More

SK Biopharma partner wins European approval for drug-resistant focal-onset seizure treatment

April 1, 2021
By Gina Lee
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
Read More
Previous 1 2 … 720 721 722 723 724 725 726 727 728 … 1359 1360 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for April 21, 2026.
  • Man holding raised arm with illustrated overlay of nerves

    Biohaven reports details on discovery of BHV-2100

    BioWorld Science
    Transient receptor potential melastatin 3 (TRPM3) is a calcium-permeable TRP channel that is highly expressed in somatosensory neurons, including nociceptors of...
  • Elderly woman holding illustration of brain with missing puzzle piece

    Meta-analysis: Anti-amyloid Alzheimer’s drugs not ‘clinically meaningful’

    BioWorld
    The ongoing controversy over the effectiveness of anti-amyloid drugs is about to get more heated, after a review of clinical trials showed statistically...
  • New GABA(B) receptor PAMs revealed in Addex Pharma patents

    BioWorld Science
    Addex Pharma SA has disclosed new GABA(B) receptor positive allosteric modulators (PAMs) potentially useful for the treatment of chronic cough, urinary...
  • MMP inhibitors divulged in Accure Therapeutics patent

    BioWorld Science
    Accure Therapeutics has reported new oligopeptide derivatives acting as matrix metalloproteinase-2 (MMP-2) and MMP-9 inhibitors. As such, they are described as...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • 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