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 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 - Sunday, January 4, 2026
Home » Topics » Regulatory, BioWorld MedTech

Regulatory, BioWorld MedTech
Regulatory, BioWorld MedTech RSS Feed RSS

Regulatory front for Feb. 16, 2021

Feb. 16, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Shuren, Stenzel push back on serology tests; FDA touts accomplishments for 2020; IMDRF posts five-year plan.
Read More

Regulatory actions for Feb. 16, 2021

Feb. 16, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Electrocore, Front Line Medical Technologies, Insightec, Luminostics, Saladax, Shockwave Medical, Smart Medical.
Read More
COVID-19 vaccine vials behind U.S. capitol building
Pfizer, Moderna agree to deliver 200M more doses

House committee inks spending package for COVID-19 pandemic

Feb. 12, 2021
By Mark McCarty
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.
Read More
Mask with Brazilian flag

Seegene strengthens footprint in Latin America via COVID testing

Feb. 12, 2021
By Gina Lee and Sergio Held
COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway. Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets.
Read More
Device image

Braincool wins breakthrough nod for system to prevent painful chemo side effect

Feb. 12, 2021
By Meg Bryant
Braincool AB has scored a breakthrough device designation from the U.S. FDA for its Cooral system, a medical cooling technology for therapeutic hypothermia and oncology. The status acknowledges Cooral’s potential to prevent oral mucositis (OM), a complication of chemotherapy.
Read More

Regulatory front for Feb. 12, 2021

Feb. 12, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
Read More

Regulatory actions for Feb. 12, 2021

Feb. 12, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson.
Read More
Calculator and pills

TGA seeks feedback on impact of proposed fee changes for drugs and devices

Feb. 12, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
Read More
Device image

Cerus Endovascular wins breakthrough status for brain aneurysm treatment

Feb. 11, 2021
By Meg Bryant
The U.S. FDA has granted breakthrough device designation to Cerus Endovascular Ltd. for its Contour neurovascular system for the treatment of intracranial aneurysms. The company is targeting the second or third quarter of this year for the start of its IDE clinical trial.
Read More
Global pandemic threat
Keeping up with the variants

Governments challenged with sequencing, tracking SARS-CoV-2 variants

Feb. 11, 2021
By Mark McCarty
Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months.
Read More
Previous 1 2 … 318 319 320 321 322 323 324 325 326 … 438 439 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 31, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Jan. 2, 2026.
  • Sickle cell illustration

    AND-017 increases RBC and hemoglobin in sickle cell disease

    BioWorld Science
    Sickle cell disease (SCD) is an inherited hemoglobinopathy caused by a mutation in the gene encoding β-globin that results in hemoglobin S polymerization, red...
  • Businessman, businesswoman handshake

    Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact

    BioWorld
    Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with...
  • Asia focused map inside light bulb

    Big pharma taps fast Asia innovation in search of next Keytruda

    BioWorld
    Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab),...
  • 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 ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing