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 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
BioWorld - Thursday, December 11, 2025
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

CDC logo on website

RFK skirts promise as CDC alters vaccine-autism webpage

Nov. 21, 2025
By Karen Carey
No Comments
Changes to a U.S. CDC website regarding autism and vaccines has sparked a backlash from numerous scientific and other groups, placing HHS Secretary Robert F. Kennedy Jr. (RFK) in the spotlight once again for appearing to break promises made earlier this year to secure his nomination.
Read More
Flag of Scotland against blue sky

Scotland sets out 10-year plan to double its life sciences sector

Nov. 21, 2025
By Nuala Moran
No Comments
The Scottish government has published a strategy setting out a roadmap to more than double the size of Scotland’s life sciences sector over the next 10 years. The most recent data show the sector currently contributes £10.5 billion (US$13.8 billion) in turnover to the economy, supporting 46,000 jobs. The aim of the strategy is to increase this to £25 billion by 2035.
Read More
In virtro fertilization

Overture Life receives CE mark for Davitri platform

Nov. 21, 2025
By Shani Alexander
Overture Life SLU secured CE mark certification for its Davitri system that automates the vitrification and thawing of oocytes and embryos, making the processes more efficient, consistent and cost-efficient. Davitri has the potential to transform IVF, giving women and families more control over their fertility timelines and ensuring every egg and embryo has the best possible chance of survival.
Read More
Probiotics, bacteria on white background
Gastrointestinal

UK study reveals inconsistencies in global microbiome research

Nov. 21, 2025
By Nuala Moran
No Comments
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.
Read More
Drug discovery illustration
Dermatologic

Fibrobiologics receives Australian HREC approvals for CYWC-628

Nov. 21, 2025
No Comments
Fibrobiologics Inc. has received public and private Human Research Ethics Committee (HREC) approvals in Australia for a phase I/II trial evaluating CYWC-628 for the treatment of refractory diabetic foot ulcers.
Read More
Gavel and scales

Fed Circuit lets Sandoz off $39M hook

Nov. 20, 2025
By Mari Serebrov
No Comments
Sandoz Inc. came out the big winner Nov. 18 when the U.S. Court of Appeals for the Federal Circuit wiped out $39 million in infringement damages a jury had awarded to Allergan plc. Sandoz overcame “the doubly high burden of persuading us to overturn a jury verdict of no invalidity,” the appellate court said in its precedential opinion.
Read More
Lungs

Bayer’s HER2-mutated lung cancer treatment gets FDA nod

Nov. 20, 2025
By Lee Landenberger
No Comments
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.
Read More
US Capitol at night

PAMA cuts for clinical lab testing averted, but overhang remains

Nov. 20, 2025
By Mark McCarty
The resolution of the budget impasse between Democrats and Republicans on Capitol Hill sidestepped a number of problems, including some cuts to Medicare payment rates for clinical laboratory testing services. However, that pause is only in effect through the end of January 2026, leaving operators of these labs with a fiscal sword of Damocles to manage.
Read More
Probiotics, bacteria on white background
Gastrointestinal

UK study reveals inconsistencies in global microbiome research

Nov. 20, 2025
By Nuala Moran
No Comments
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.
Read More
Probiotics, bacteria on white background

UK study reveals inconsistencies in global microbiome research

Nov. 19, 2025
By Nuala Moran
No Comments
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.
Read More
Previous 1 2 3 4 5 6 7 8 9 10 11 … 1319 1320 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 11, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Dec. 11, 2025.
  • Novo Nordisk semaglutide pill

    CTAD 2025: Diagnosing semaglutide’s failure in Alzheimer’s trials

    BioWorld
    A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow cognition decline in patients with...
  • RFK at Senate HELP meeting 5-14

    US lawmakers demand that Kennedy be held accountable

    BioWorld
    As the systematic dismantling of the U.S. vaccine schedule escalates, the demands to hold Health and Human Services Secretary Robert Kennedy accountable are...
  • Red dollar sign under microscope

    Medline plans record-setting $5.37B IPO

    BioWorld MedTech
    Almost a year since first filing its S-1 to return to public markets, Medline Inc. revealed the price range for the most awaited IPO of 2025. The massive medical...
  • 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 ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing