BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Sunday, July 6, 2025
Home » Topics » Regulatory » EMA

EMA
EMA RSS Feed RSS

EU flag, pills, syringe

EMA’s CHMP backs new antibiotic, oral PNH drug in March meeting

March 26, 2024
By Jennifer Boggs
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria.
Read More
EU flag, pills, syringe

EMA’s CHMP backs new antibiotic, oral PNH drug in March meeting

March 22, 2024
By Jennifer Boggs
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe.
Read More
EU flags

EU’s largest pharma reform in 20+ years advances, despite concerns

March 20, 2024
By Nuala Moran
After months of wrangling, the update of the EU pharmaceutical legislation passed an important milestone on March 19, when members of parliament on the health committee reconciled their opposing views and voted the file through.
Read More
World map with connecting lines
2024 IMDRF Annual Meeting

Med-tech regulatory flux in play across the globe

March 12, 2024
By Mark McCarty
Regulatory harmonization and reliance are the orders of the day at this year’s meeting of the International Medical Device Regulators Forum (IMDRF), but that does not mean individual regulators are waiting for IMDRF to act on their own imperatives.
Read More

EMA validates two filings for Daiichi-Astrazeneca’s ADC

March 5, 2024
By Marian (YoonJee) Chu
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
Read More

EMA validates two filings for Daiichi-Astrazeneca’s ADC

March 4, 2024
By Marian (YoonJee) Chu
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
Read More

Aribio gains UK approval to start phase III trial of Alzheimer’s drug

Feb. 27, 2024
By Marian (YoonJee) Chu
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
Read More

Aribio gains UK approval to start phase III trial of Alzheimer’s drug

Feb. 26, 2024
By Marian (YoonJee) Chu
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
Read More
EU flag, syringe, capsules

Sparsentan and two bird flu vaccines in EU positive opinion list

Feb. 23, 2024
By Caroline Richards
Seven new therapies, including two influenza vaccines, were recommended for approval by the EMA’s Committee for Medicinal Products for Human Use during its February 2024 meeting. One of these was sparsentan by CSL Vifor Pharma Inc. and Travere Therapeutics Inc. for the treatment of IgA nephropathy (IgAN), for which the committee has awarded conditional marketing authorization.
Read More

EMA pulling Translarna off market for Duchenne muscular dystrophy

Jan. 26, 2024
By Nuala Moran
After almost 10 years on the market, the EMA is to withdraw its conditional approval of the Duchenne muscular dystrophy treatment Translarna (ataluren), after concluding there is still not enough evidence of its effectiveness.
Read More
Previous 1 2 3 4 5 6 7 8 9 10 11 12 … 156 157 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 3, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 3, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 1, 2025
  • Illustration of the β2-adrenergic receptor

    Exercise-mimicking compound offers alternative to GLP-1 therapies

    BioWorld
    An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR)...
  • Robert Paris, vice president, Moderna

    Moderna expands mRNA tech to latent viruses, cancer, rare disease

    BioWorld
    Post pandemic, Moderna Inc. is broadening the applications of mRNA technology to cancer, rare diseases, latent viruses and respiratory viruses, “taking advantage”...
  • 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
    • 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