• 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
  • 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
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • 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
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

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

Regulatory
Regulatory RSS Feed RSS

Advisory panel urges FDA to reclassify three in vitro diagnostic tests

Sep. 27, 2023
By Mark McCarty
The U.S. FDA recently convened an advisory hearing to discuss whether three in vitro diagnostics should be reclassified from class III to class II, including tests for the pathogens responsible for Hepatitis B and tuberculosis. The panel agreed that all three of the test types should be reshuffled to the lower-risk class II category, suggesting that test developers now have an opportunity to jump into a market with lower-cost tests that won’t need expensive and drawn-out clinical studies to obtain the FDA’s seal of approval.
Read More

Regulatory actions for Sept. 27, 2023

Sep. 27, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Laminate Medical Tecnologies.
Read More

Regulatory actions for Sept. 27, 2023

Sep. 27, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Affamed, Akebia, Altrubio, Biostem, Cel-Sci, Chrysalis, Defender, Ideaya, Mythic, Phathom, Sandoz, Sanofi, Veru.
Read More
Pathways illustration

Going forward, regulatory flexibility essential in biosimilar realm

Sep. 26, 2023
By Mari Serebrov
As biosimilar development expands beyond monoclonal antibodies to more complex biologics, the flexibility built into regulatory paths across the world will become more essential. Rather than making wholesale changes to those pathways, regulators need to follow the science in exercising the flexibility they already have, Leah Christl, executive director of global biosimilars regulatory affairs and R&D policy at Amgen Inc., told BioWorld. In doing so, “we do need to look forward to what might be coming down the pipeline,” in addition to looking backwards at what types of biosimilars have already been approved, she said.
Read More

Japan’s MHLW approves slew of new drugs, including Eisai/Biogen’s Leqembi for Alzheimer’s

Sep. 26, 2023
By Tamra Sami
Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.
Read More

Regulatory actions for Sept. 26, 2023

Sep. 26, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Alvotech, Appili, Ardelyx, Biogen, Biora, Cara, Coherus, Daewoong, Eisai, Genmab, Nymox, Pfizer, Sanofi, Shuttle, Takeda, Theratechnologies, Tris.
Read More
femaseed illustration

FDA clearance enables Femaseed to help families grow

Sep. 26, 2023
By Annette Boyle
Femasys Inc. received U.S. FDA 510(k) clearance for Femaseed, an infertility treatment that delivers sperm directly to the fallopian tubes. Less invasive and more straightforward than in vitro fertilization, the procedure offers what the company said is a new and more affordable alternative to family building for couples encountering fertility issues.
Read More
Gavel with whistle

Zap Surgical prevails over Elekta in Federal Circuit patent scrum

Sep. 26, 2023
By Mark McCarty
Patent challenges for radiotherapy equipment might not make the splash that in vitro diagnostic patents have, but Elekta AB and Zap Surgical Inc., have been locked in a dispute over an Elekta patent for the past four years.
Read More

FDA’s premarket cybersecurity guidance encodes legislative imperatives

Sep. 26, 2023
By Mark McCarty
The Consolidated Appropriations Act of 2023 covered a lot of budget terrain for the U.S. federal government, but Section 3305 was unusual for this type of bill in that it called on the FDA to require cybersecurity features as a part of the Quality System Regulation (QSR).
Read More

Regulatory actions for Sept. 26, 2023

Sep. 26, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abyrx, Femasys, Profound Medical, Profound Medical, Saluda Medical.
Read More
Previous 1 2 … 225 226 227 228 229 230 231 232 233 … 1259 1260 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 9, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 9, 2025.
  • Red blood cells in an artery with cholesterol

    In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

    BioWorld
    In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant...
  • Neuronata-R

    Corestemchemon preps US BLA filing for stem cell ALS therapy

    BioWorld
    Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 10, 2025
  • 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
    • 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
  • 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
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe