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
    • BCI
    • 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 - Monday, July 13, 2026
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Pakistan flag-map

Import bans hit Pakistan’s pharma industry

Aug. 11, 2020
By Khawar Khan
KARACHI, Pakistan – Geopolitics and a fraught relationship with its neighbors are hurting Pakistan’s pharmaceutical industry and the ability of people to access active pharmaceutical ingredients (APIs) and modern drugs.
Read More

Fennec's Pedmark lands CRL over manufacturing issues

Aug. 11, 2020
By Michael Fitzhugh
Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors.
Read More
COVID-19 vaccine vials

From Russia with flub? Safety jitters ripple after quick COVID-19 vaccine approval

Aug. 11, 2020
By Randy Osborne
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
Read More
Financial chart, downward arrow

Mesoblast sees stock tumble 31% ahead of FDA adcom meeting

Aug. 11, 2020
By Tamra Sami
PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
Read More
U.S. Capitol building

Domestic Rx, device supply chain a tall order

Aug. 11, 2020
By Mari Serebrov
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
Read More

Regulatory front for Aug. 11, 2020

Aug. 11, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Allergan, BTL Industries, Spartan Bioscience, Zimmer Medizinsysteme.
Read More

Regulatory actions for Aug. 11, 2020

Aug. 11, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Life Spine, Magventure, United Imaging.
Read More

Regulatory front for Aug. 11, 2020

Aug. 11, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Kodak, Moderna.
Read More

Regulatory actions for Aug. 11, 2020

Aug. 11, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Gene Technologies, Arvelle, Atyr, Clearside, Equillium, Fennec, Kyorin, Mersana, Mesoblast, Neurogene, Protalix.
Read More
Fingerprick blood test

TGA approves Atomo Diagnostics’ rapid COVID-19 antibody test

Aug. 10, 2020
By Tamra Sami
PERTH, Australia – As the state of Victoria in Australia records its deadliest day since the COVID-19 pandemic began, reporting 17 deaths and 394 new cases, Atomo Diagnostics Ltd.’s new COVID-19 antibody test could ease pressure on health care systems.
Read More
Previous 1 2 … 863 864 865 866 867 868 869 870 871 … 1377 1378 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 10, 2026.
  • Art concept for medical research

    FENS 2026: Shedding light on the sheddome

    BioWorld
    At the recently opened FENS Forum 2026 in Barcelona – the Federation of European Neuroscience Societies’ flagship congress and Europe’s largest neuroscience...
  • Silhouette with keyhole

    FENS 2026: Next-gen biologics take on brain disease

    BioWorld
    Whether by fine-tuning neurotransmitter signaling or silencing disease-associated genes, emerging biologic therapies are reshaping neuroscience drug development,...
  • Wainua autoinjector

    Ionis, AZ shares down on unexpected Wainua flop in cardiomyopathy

    BioWorld
    News of the unexpected phase III failure of the gene silencing drug Wainua (eplontersen) in the treatment of transthyretin-mediated amyloid cardiomyopathy sent...
  • NRF2 activators reported in Vailima Peninsula patent

    BioWorld Science
    Vailima Peninsula Pty Ltd. has discovered new nuclear factor erythroid 2-related factor 2 (NFE2L2; NRF2) activators 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