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 - Thursday, May 28, 2026
Breaking News: Ongoing coverage of the Ebola outbreakBreaking News: Ongoing coverage of the Ebola outbreak
Home » Topics » BioWorld, Regulatory

BioWorld, Regulatory
BioWorld, Regulatory RSS Feed RSS

Vaccine administration

Anvisa restarts trials for Sinovac’s COVID-19 vaccine

Nov. 12, 2020
By Sergio Held and Alfred Romann
BOGOTA, Colombia and VANCOUVER, Canada – Anvisa, Brazil’s health care surveillance agency, re-started phase III trials for Coronavac, the COVID-19 vaccine candidate developed by China-based Sinovac Biotech Ltd., after a suspension of just two days. “Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” the regulator said on Nov. 11. Anvisa said it plans to continue monitoring “the possible relationship of causality” between an unexpected serious adverse event and the vaccine.
Read More
Regulatory front

NICE news for patients with CLL, TTP

Nov. 12, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
Read More

Regulatory actions for Nov. 12, 2020

Nov. 12, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Apollomics, Bavarian Nordic, Halozyme, Janssen, Mycovia, Neonmind, Valeo, Vasomune.
Read More
Regulatory front

ICER adjusts Veklury price models – again

Nov. 11, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: MHRA advises on minimizing trial disruptions.
Read More

Regulatory actions for Nov. 11, 2020

Nov. 11, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiocrine, Bioxcel, Gyroscope, Inventiva, Sebela, Sorrento, Surface.
Read More

Lilly’s COVID-19 antibody has emergency use authorization; who will receive it?

Nov. 10, 2020
By Lee Landenberger
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
Read More
Regulatory front

Fed Circuit prolongs inventorship battle

Nov. 10, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: CDC updates vaccine guidance; Russia launches doctor-driven shortage reporting service; MHRA reviewing acne drug risks.
Read More

Regulatory actions for Nov. 10, 2020

Nov. 10, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Clinigen, Emmaus, Forma, Immune-Onc, Lilly, Oryzon, Praxis, Rafael, Supernus.
Read More

Regulatory actions for Nov. 9, 2020

Nov. 9, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amo, Astrazeneca, Axovant, Bayer, Beigene, Eusa, Impel, Liminal, Novavax, Orphazyme, Sorrento.
Read More
Regulatory front

FDA: COVID-19 shows why diversity needed in trials

Nov. 9, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Final analysis: hydroxychloroquine offers no benefit; FDA finalizes PDUFA VI fee guidance.
Read More
Previous 1 2 … 383 384 385 386 387 388 389 390 391 … 457 458 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 27, 2026.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for May 26, 2026
  • 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...
  • In the clinic for May 26, 2026

    BioWorld
    Clinical updates for biopharma and med tech, including data readouts and publications: 858, A2 Biotherapeutics, AC Immune, Agendia, Agenus, Aktis, Ascentage,...
  • 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