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
    • Ebola outbreak
    • Hantavirus
    • 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 - Saturday, May 30, 2026
Home » Topics » Regulatory » Policy

Policy
Policy RSS Feed RSS

U.S. Capitol building, Washington D.C.

House passes H.R. 1, restoring R&D tax cuts

July 3, 2025
By Mark McCarty
The House of Representatives passed H.R. 1, also known as One Big Beautiful Bill, which will restore personal income tax cuts that expired in 2022. However, the bill also restores research and development tax credits, a provision that drew immediate praise from industry.
Read More
Judge's gavel with US flag

Another court orders halt to US HHS reorganization

July 1, 2025
By Mari Serebrov
No Comments
Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.
Read More

ACIP questions remain unanswered

July 1, 2025
By Mari Serebrov
No Comments
While the first meeting of the U.S. CDC’s newly minted Advisory Committee for Immunization Practices (ACIP) is now recent history, questions about the makeup of the committee and its future direction remain unanswered.
Read More
U.S. Supreme Court

Supreme Court upholds ACA’s preventive care coverage

June 27, 2025
By Annette Boyle
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
Read More
Laptop displaying FDA logo

FDA waffles on post-assessment reports in final guidance for RRAs

June 27, 2025
By Mark McCarty
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
Read More
Laptop displaying FDA logo

FDA waffles on post-assessment reports in final guidance for RRAs

June 26, 2025
By Mark McCarty
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
Read More
Enflonsia

ACIP delivers good news for Merck, makes unprecedented precedent

June 26, 2025
By Mari Serebrov
No Comments
Despite the controversies swirling around the June meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP), the reconstituted committee delivered good news to Merck & Co. Inc. when it voted 5-2 June 26 to recommend that infants younger than 8 months who are not protected by maternal vaccination get one dose of a monoclonal as they head into their first respiratory syncytial virus season.
Read More
U.S. Capitol building, Washington D.C.

Remote patient monitoring shortchanged by Medicare

June 25, 2025
By Mark McCarty
A June 25 hearing in the U.S. House of Representatives highlighted some of the health care spending benefits of remote patient monitoring, but Medicare payment is seen as deficient – a problem that may be resolved by pending legislation.
Read More
Martin Kulldorf, ACIP chair

No vote, ACIP recurring theme at CDC confirmation hearing

June 25, 2025
By Mari Serebrov
No Comments
Although the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) was scheduled to vote June 25 on recommendations for maternal and pediatric respiratory syncytial virus vaccines, it adjourned by pushing that vote to the second day of the meeting. But before leaving for the day, it got an earful of comments from pediatricians, nurses and even a retired FDA scientist urging the CDC to reinstate the 17 committee members Health and Human Services Secretary Robert Kennedy dismissed two weeks earlier and replaced with eight new members.
Read More
US flag and HHS logo

HHS, payers vow to fix prior authorization problem

June 24, 2025
By Mark McCarty
The Department of Health and Human Services and private payers have promised to streamline the controversial prior authorization processes in a bid to reduce the attendant controversies.
Read More
Previous 1 2 … 13 14 15 16 17 18 19 20 21 … 33 34 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 29, 2026.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for May 26, 2026
  • Floating antibody drug conjugates

    TROP2 ADCs progress into first-line for lung, breast cancers

    BioWorld
    Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for...
  • Microscopy of a cross-section of mouse skin containing melanoma tumors

    Researchers identify innate immune barrier against melanoma

    BioWorld
    Australian researchers have identified a previously overlooked population of immune cells in the skin that physically restrain melanoma growth by engulfing live...
  • Cavalon Therapeutics and Northwestern patent new Cav1.3 blockers

    BioWorld Science
    Cavalon Therapeutics Inc. and Northwestern University have disclosed new voltage-gated calcium channel Cav1.3 blockers potentially useful for the treatment of...
  • 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