News

US FDA approves an updated label for TRYVIO (aprocitentan) removing the REMS requirement
Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is, I believe, a ...
Pharmabiz22d
MMS Holdings’ REMS-focused technology bolsters full-service risk evaluation and mitigation strategy solutions
showcased a presentation by CEO Dr. Uma Sharma at the REMS (risk evaluation and mitigation strategies) Industry Consortium Annual Meeting in Arlington, Virginia. The integration of proprietary ...
Monthly Prescribing Reference26d
FDA Determines REMS No Longer Necessary for Tryvio
Prescribers and pharmacists are no longer expected to comply with the REMS for Tryvio. The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategies (REMS ...
TCTMD2d
FDA Drops REMS Requirement for Antihypertensive Aprocitentan
The drug was approved last year for patients with hypertension currently not controlled on other BP-lowering agents.
The Pharma Letter3d
FDA removes REMS requirement from Idorsia’s Tryvio label
Swiss biopharma Idorsia (SIX: IDIA) has received approval from the US Food and Drug Administration for an updated label on ...
JD Supra2d
Five Strategies to Mitigate a New Risk Environment
Legal and compliance officers are used to adjustments and continuous improvement of their compliance programs. Building and maintaining an ...
Yahoo Finance26d
US FDA removes REMS requirement for TRYVIO (aprocitentan) – minimizing the burden on the healthcare delivery systems and patients
Idorsia Ltd (SIX: IDIA) today announced that – effective immediately – the US FDA has fully released TRYVIO™ (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy ...
Seeking Alpha9d
Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA ...
Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program 1 Phase III data showed ...
KXAN9d
Novartis receives FDA accelerated approval for Vanrafia®
Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program 1 Phase III data showed ...