Drugs

FDA Accepts NDA for Once-Daily ADHD Drug

FDA has accepted for review a Cingulate NDA for CTx-1301 (dexmethylphenidate), a once-daily stimulant designed to treat attention-deficit/hyperactivity disorder in children and adults. CTx-1301 uses Cingulate’s precision timed release technology to deliver three timed doses of dexmethylphenidate throughout the day, according to the company. The agency has set a 5/31/2026 user fee review action target date.

The NDA was submitted under FDA’s 505(b)(2) regulatory pathway that allows reliance on data from approved drugs to support approval. The company says its NDA is also supported by Phase 3 trials showing significant and sustained improvements across key efficacy measures, including the Permanent Product Measure of Performance and Adult ADHD Investigator Symptom Rating Scale in adults, and the ADHD Rating Scale-5 and Clinical Global Impression scale in children.

Cingulate says no serious treatment-emergent adverse events were reported, and CTx-1301’s safety profile was consistent with other long-acting methylphenidate products.

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