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
    • 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
BioWorld - Sunday, June 29, 2025
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Infant exam

China prioritizes mental health, pediatric care in 2025

Feb. 19, 2025
By Marian (YoonJee) Chu
China’s National Health Commission is designating a three-year period from 2025 to 2027 as the “years of pediatric and mental health services,” in line with a new pledge to achieve eight initiatives in the health care sector aimed at servicing underserved populations.
Read More
Monica Bertagnolli, former director, U.S. NIH
Policy

AAAS 2025: Former NIH head Bertagnolli sounds warning on funding cuts

Feb. 19, 2025
By Nuala Moran
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.
Read More
Monica Bertagnolli, former director, U.S. NIH

AAAS 2025: Former NIH head Bertagnolli sounds warning on funding cuts

Feb. 18, 2025
By Nuala Moran
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.
Read More
Hand holding a pink slip or termination notice against a blurred office background

Thousands of US HHS staff terminated in name of efficiency

Feb. 18, 2025
By Mari Serebrov
As part of a U.S. government-wide reduction in force aimed at restructuring and streamlining federal agencies, 5,200 Health and Human Services employees reportedly received their pink slips over the weekend, with 1,165, or 22%, of those at the NIH.
Read More

New chikungunya vaccine from Bavarian Nordic wins FDA nod

Feb. 18, 2025
By Lee Landenberger
With the U.S. FDA’s approval of Vimkunya, Bavarian Nordic A/S is now in the chikungunya virus infection mix along with Valneva SE’s Ixchiq. A single-dose, adjuvanted virus-like particle-based vaccine to protect against the chikungunya virus infection, Vimkunya is the first of its kind available in the U.S. for those age 12 and older.
Read More

GSK’s meningitis vaccine second pentavalent approved by the FDA

Feb. 18, 2025
By Lee Landenberger
A second pentavalent vaccine for preventing meningococcal disease has been approved by the U.S. FDA. GSL plc’s Penmenvy will now go up against Pfizer Inc.’s Penbraya, which had a two-year head start in the market.
Read More
FDA Approved stamp with pills

Deciphera’s Romvimza wins FDA nod for tenosynovial giant cell tumors

Feb. 18, 2025
By Karen Carey
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects.
Read More
FDA vaccine illustration

FDA approves vaccines for chikungunya, meningococcal disease

Feb. 18, 2025
By Lee Landenberger

Guillain-Barré case puts Moderna norovirus vax trial on hold

Feb. 14, 2025
By Karen Carey
Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
Read More
Roche building

​US FDA clears Roche’s preeclampsia test

Feb. 14, 2025
By Annette Boyle
With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.
Read More
Previous 1 2 … 42 43 44 45 46 47 48 49 50 … 1266 1267 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 27, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 27, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 24, 2025
  • BIO2025: John Crowley and Martin Makary

    BIO 2025: Makary lays out FDA’s path, launches pilot review program

    BioWorld
    On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the...
  • Andembry

    New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

    BioWorld
    Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa...
  • 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