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
BioWorld - Sunday, June 15, 2025

Regulatory front

Home » Topics » Regulatory front
  • Sep. 6, 2022
    By Doris Yu

    Sinocelltech receives first NMPA approval for a homegrown anti-CD20 MAb

    Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.
  • Sep. 1, 2022
    By Doris Yu

    Sinocelltech receives first NMPA approval for a homegrown anti-CD20 MAb

    Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.
  • Fda website and logo
    March 2, 2022
    By Mari Serebrov

    US FDA final guidances part of cancer moonshot payload

    Ahead of U.S. President Joe Biden’s State of the Union address March 1 in which he gave a shoutout to his cancer moonshot initiative, the FDA released a trio of final guidances aimed at speeding the development of new cancer drugs. First launched in 2016 with the goal of doubling the rate of progress against cancer by making a decade worth of advances in five years, the moonshot was reignited last month with a new target following setbacks in cancer screenings and treatments during the COVID-19 pandemic. Now, Biden’s catch phrase is “ending cancer as we know it.”
Read More

Authors

  • Mark McCarty
  • Mari Serebrov
  • Nuala Moran
  • Marie Powers
  • Holland Johnson
  • Meg Bryant
More Authors
  • 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