The FDA has removed the risk evaluation and mitigation strategies (REMS) program requirement for Tryvio (aprocitentan).

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 ...

The ANC testing is part of labeling, as the drug poses a risk for neutropenia. The REMS required that physicians and pharmacists be certified to prescribe and dispense the drug, which was ...

The FDA still recommends prescribers monitor patients’ ANC levels according to the prescribing information. The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation ...

Ad hoc announcement pursuant to Art. 53 LR FDA confirms that prescribers and pharmacists are no longer expected to interact ...

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has suggested he is open to restricting access to abortion medication, the primary method used for abortions across the U.S. Kennedy ...

Health experts who spoke to The Hill agreed the easiest way Kennedy could change access to the drug is through trying to alter its Risk Evaluation and Mitigation Strategies (REMS). REMS are ...

MMS, an award-winning, data-focused clinical research organization (CRO), is showcasing its expansion as a tech-enabled, full-service Risk Evaluation and Mitigation Strategies (REMS) solutions ...

For 35 years, the FDA has placed onerous restrictions on the only drug it has ever approved for treatment-resistant ...

Unless you’re lucky to fly in a class with a lie-flat seat, you’re unlikely to step off a long-haul flight having had a ...

NDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGSIf approved, FILSPARI could become the first and ...