News about "Risk Evaluation and Mitigation Strategy "

Organon Wins FDA Approval to Extend Duration of Use for NEXPLANON

Organon Wins FDA Approval to Extend Duration of Use for NEXPLANON

Organon has received US Food and Drug Administration (FDA) approval for a supplemental New Drug Application extending the duration of use of NEXPLANON, its etonogestrel radiopaque contraceptive implant, to up to five years, expanding the product’s earlier three-year indication and offering longer-lasting contraceptive protection.

Risk Evaluation And Mitigation Strategy | 17/01/2026 | By News Bureau 325

US FDA Approves Agios' AQVESME for Thalassemia-Related Anaemia

US FDA Approves Agios' AQVESME for Thalassemia-Related Anaemia

The US FDA has approved Agios’ AQVESME for the treatment of anaemia in adults with thalassemia, making it the only approved therapy for both transfusion-dependent and non-transfusion-dependent patients. The drug will be marketed in the US under the AQVESME brand for thalassemia, with availability expected in late January 2026.

Risk Evaluation And Mitigation Strategy | 24/12/2025 | By News Bureau 103


 

 

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