Drugs

Madrigal’s Resmetirom Hits Phase 3 NASH Endpoints

Madrigal Pharmaceuticals says its resmetirom, a liver-directed selective thyroid hormone receptor agonist, met both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for treating nonalcoholic steatohepatitis (NASH) with liver fibrosis. A company statement reported results from the pivotal Phase 3 MAESTRO-NASH registrational trial.

The statement says the drug was safe and well-tolerated at both 80 mg and 100 mg doses. It says the frequency of serious adverse events was similar across treatment arms for the 80 mg, 100 mg, and placebo groups, respectively. The most common adverse events reported with greater frequency in the resmetirom groups versus placebo were an excess of mild and transient diarrheas at the beginning of therapy and generally mild nausea.

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

Read more

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