Drugs

FDA Drops REMS Need for ERA Meds

FDA says a new analysis of human pregnancy data compiled from the use of endothelin receptor antagonist (ERA) medicines for 20 years found that REMS requirements about embryofetal toxicity (EFT) risk are no longer needed. A notice says the agency believes that labeling alone is adequate to communicate the risk, and labeling will continue to inform healthcare professionals and patients about the risk.

As of 4/2025, the notice says, the REMS was eliminated for Letaris and generics (ambrisentan), Opsumit and generics (macitentan), Opsynvi (macitentan and tadalafil), and Tryvio (aprocitentan).

FDA says it also notified manufacturers of Traceleer and generics (bosentan) and Filspari (sparsentan) that they must modify the REMS to remove requirements related to EFT risk.

“FDA’s ERA REMS requirements for EFT risk were based on findings from animal studies,” the notice says. “Over time, the agency monitored clinical outcomes in patients exposed to ERA medicines during pregnancy and observed that these data did not show a pattern of congenital malformations consistent with what was observed in animal EFT studies. Given the agency’s new analysis and understanding of clinical risk, FDA determined that labeling for all ERA medicines is sufficient to provide information about EFT risk and its mitigation.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome