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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, July 18, 2025
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Congress, states staging Act 2 of US Rx pricing reforms

May 23, 2023
By Mari Serebrov
When it comes to cutting health care costs in the U.S., last year’s Inflation Reduction Act, with its inflationary rebates and direct Medicare negotiations, was just Act 1. Now lawmakers, in both the House and Senate, are feverishly working on bipartisan scripts for Act 2 that go beyond biopharma’s role in drug prices to taking on pricing issues across the health care sector.
Read More
Hepatitis C virus

China's NMPA approves Sanhome’s alfosbuvir for HCV

May 23, 2023
By Zhang Mengying
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
Read More

Regulatory actions for May 23, 2023

May 23, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Bioarctic, Biocryst, Centessa, Eisai, Freeline, Grunenthal, Hanx, Ideaya, Laekna, Polypid, Sangamo, Xbiotech.
Read More

Regulatory actions for May 22, 2023

May 22, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beta Bionics, Orlucent.
Read More
NovasightHybridSystem.jpg

China grants marketing approval for a hybrid intravascular imaging system

May 22, 2023
By Doris Yu
Grand Pharmaceutical Group Ltd. obtained China’s NMPA approval for an intravascular dual-mode imaging system for coronary artery imaging, tapping into a potentially huge but very undeveloped market for imaging in percutaneous coronary interventions (PCI).
Read More

China's NMPA approves Sanhome’s alfosbuvir for HCV

May 22, 2023
By Zhang Mengying
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
Read More
Leqembi

Pressure mounts for CMS coverage ahead of Leqembi’s ‘full’ approval date

May 22, 2023
By Mari Serebrov
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
Read More

Regulatory actions for May 22, 2023

May 22, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Pfizer, Rznomics, Sanofi, Satsuma, Sobi.
Read More
FDA approved icons and medical professional

Genmab, Abbvie to join Roche with FDA nod for CD20 bispecific in lymphoma

May 19, 2023
By Jennifer Boggs
Five months after the first anti-CD20xCD3 T-cell engaging bispecific antibody, Roche Holding AG’s Lunsumio (mosunetuzumab), cleared U.S. FDA approval for follicular lymphoma, partners Genmab A/S and Abbvie Inc. won the agency’s approval for epcoritamab as the first subcutaneous CD20xCD3 bispecific antibody for treating diffuse large B-cell lymphoma.
Read More

Regulatory actions for May 19, 2023

May 19, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Hologic, Neurophet, Thermo Fisher, Volta Medical.
Read More
Previous 1 2 … 299 300 301 302 303 304 305 306 307 … 1275 1276 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 17, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 17, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 15, 2025
  • Brain and neural networks

    Proteomics finds surprise commonalities as well as differences in neurodegenerative diseases

    BioWorld
    The switch will be flicked today to make the world’s largest dementia-related proteomics dataset freely available to researchers, at the same time as members of...
  • 3D rendering of a molecular glue mediating the interaction between two proteins

    With surface mimicry, molecular glues shed hairpin need

    BioWorld Science
    Degradation is a therapeutic strategy that could offer possibilities to get at currently undruggable target proteins. In targeted degradation, compounds induce...
  • 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