MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

Omeros to Host Conference Call Monday, December 29, 2025 at 4:30 p.m. ET -- -- First and only approved option: YARTEMLEA(R) is the only approved treatment for hematopoietic stem cell ...

Dublin, Dec. 23, 2025 (GLOBE NEWSWIRE) -- The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course ...

The U.S. Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc (NASDAQ: AZN) and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for patients with a ...

TOKYO & MUNICH, December 18, 2025--(BUSINESS WIRE)--The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY ® (datopotamab deruxtecan) ...

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY ® (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult ...

Omeros Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved YARTEMLEA® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated ...

Omeros Corporation today announced a revised date for its conference call to discuss the recent FDA approval of YARTEMLEA® (narsoplimab-wuug), the first and only therapy indicated for hematopoietic ...

Eurostat reported that renewable energy accounted for 49.3 per cent of net electricity generated across the EU in the third quarter of 2025, a development that highlights wide disparities among member ...

Amy McCarthy is a reporter at Eater.com, focusing on pop culture, policy and labor, and only the weirdest online trends. Earlier this week, representatives from the Food and Drug Administration (FDA) ...