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 - Wednesday, December 24, 2025
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
Regulatory, BioWorld RSS Feed RSS

U.S. Capitol building

Domestic Rx, device supply chain a tall order

Aug. 10, 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. 10, 2020

Aug. 10, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Aurinia, Glaxosmithkline.
Read More

Regulatory actions for Aug. 10, 2020

Aug. 10, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Aquestive, Chi-Med, Diurnal, Gilead, Mallinckrodt, Ocugen, Pluristem, Reata, Seelos, Trevena, Vaxart.
Read More

PTC’s risdiplam gets FDA nod as first at-home SMA therapy

Aug. 7, 2020
By Jennifer Boggs
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
Read More
Triatomine insect on target

Bayer’s Lampit approved by FDA for treating Chagas disease

Aug. 7, 2020
By Lee Landenberger
Bayer AG’s Lampit (nifurtimox) to treat Chagas disease in pediatric patients, approved by the FDA on Friday, is an oral, antiprotozoal medication for newborns to patients under 18, who weigh at least 2.5 kg and are diagnosed with Chagas disease caused by Trypanosoma cruzi.
Read More
Amyloid plaque on nerve cell

Yes we aducanumab? Biogen/Eisai AD bid gains traction, outlook still divided

Aug. 7, 2020
By Randy Osborne
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.
Read More
Pakistan flag-map

Import bans hit Pakistan’s pharma industry

Aug. 7, 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

Regulatory actions for Aug. 7, 2020

Aug. 7, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Canbridge, Cytodyn, Eisai, Intellia, Kazia, PTC, Roche, Viiv.
Read More

FDA clears GSK’s Blenrep in multiple myeloma; black box and REMS for eye tox

Aug. 6, 2020
By Randy Osborne
About two weeks after European regulators gave their go-ahead for Blenrep (belantamab mafodotin-blmf), the B cell maturation antigen (BCMA)-targeting therapy from Glaxosmithkline plc (GSK) for relapsed/refractory multiple myeloma (MM), the FDA did likewise.
Read More

Regulatory front for Aug. 6, 2020

Aug. 6, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Insmed, Kodak, Mylan.
Read More
Previous 1 2 … 377 378 379 380 381 382 383 384 385 … 431 432 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 23, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Dec. 23, 2025.
  • Illustration of magnifying glass looking at cancer in the brain

    Researchers discover how glioblastoma tumors dodge chemotherapy

    BioWorld MedTech
    Researchers at the University of Sydney have uncovered a mechanism that may explain why glioblastoma returns after treatment, and the world-first discovery offers...
  • Illustration of brain with electrical activity background

    ABS-1230 controls seizures in KCNT1-driven severe epilepsy

    BioWorld Science
    Mutations in the KCNT1 gene produce gain-of-function effects that lead to overactivation of the potassium channel and consequent disruption of normal neuronal...
  • Acute myeloid leukemia illustration

    Apollo’s APL-4098 shows potent antileukemic effects

    BioWorld Science
    Apollo Therapeutics Ltd. has developed APL-4098, a small-molecule general control nonderepressible 2 (GCN2) inhibitor for the potential treatment of AML.
  • 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 ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing