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 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 - Friday, January 2, 2026
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Regulatory front for Jan. 24, 2020

Jan. 24, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, First Coast Services Options, Livanova, Medline Industries, National Institute for Health and Care Excellence, Novitas Solutions
Read More
FDA Approved stamp

Tazemeto, stat: Accelerated win for Epizyme in ES could ‘reFLect’ well in bigger indication

Jan. 24, 2020
By Randy Osborne
Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.
Read More
Blocks with upward arrows

Australia’s TGA proposes fee increases to implement recent drug, device reforms

Jan. 24, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
Read More

Regulatory front for Jan. 24, 2020

Jan. 24, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Sage Therapeutics
Read More

Anerem approved in Japan for general anesthesia

Jan. 24, 2020

Japanese approval for Corectim ointment for atopic dermatitis

Jan. 24, 2020

FDA grants accelerated approval of Tazverik for epithelioid sarcoma

Jan. 24, 2020

Dotinurad receives Japanese approval for hyperuricemia

Jan. 24, 2020

Regulatory front for Jan. 23, 2020

Jan. 23, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Cowen Washington Research Group, European Commission, GE Healthcare
Read More
Gavel and scales

Securities class action suits a growing fact of life for life sciences

Jan. 23, 2020
By Mari Serebrov
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.
Read More
Previous 1 2 … 906 907 908 909 910 911 912 913 914 … 1326 1327 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 31, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Dec. 31, 2025.
  • Businessman, businesswoman handshake

    Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact

    BioWorld
    Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with...
  • Asia focused map inside light bulb

    Big pharma taps fast Asia innovation in search of next Keytruda

    BioWorld
    Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab),...
  • IMV-101 shows promise for B-cell malignancies

    BioWorld Science
    IMV-101 is a new CAR T-cell therapy targeting CD19 developed by Suzhou Immunofoco Biotechnology Co. Ltd. for the potential treatment of B-cell malignancies and...
  • 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 ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing