Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate

Submitted by Anonyme on 2026-07-31T09:15:01+02:00
Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment...
Anglais

Datroway® Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy

Submitted by Anonyme on 2026-07-31T09:15:01+02:00
Datroway®(datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are...
Anglais

SES: Disclosure of Share Buyback Transactions

Submitted by Anonyme on 2026-07-31T08:15:01+02:00
In the time period from June 2, 2026 until and including June 23, 2026, a number of 213,167 shares were bought back within the framework of the share buyback of SES to meet obligations...
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SES Publishes FY2025 EU Taxonomy Restatement

Submitted by Anonyme on 2026-07-31T08:15:01+02:00
SES today published a restatement of its FY2025 EU Taxonomy (Article 8) disclosure. The restatement updates the FY2025 EU Taxonomy disclosure included in the 2025 Annual Report and supersedes the previously published disclosure. The FY2025 EU Taxonomy Restatement is available...
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