Drugs

FDA Partial Clinical Hold on Biohaven Epilepsy Drug

FDA has issued a partial clinical hold on Biohaven’s opakalim (BHV-7000) due to “nonclinical characterization of certain metabolites” documented in rodent testing, according to the company.

“It was determined that there was insufficient information related to a specific metabolite to assess risks of that metabolite to human subjects at this time,” the company says in a financial filing. “Thus, FDA instructed the company to pause new enrollment until additional clarifying nonclinical studies are completed, and issued a partial clinical hold letter on 9/4 that pauses new patient enrollment pending the results of additional nonclinical data regarding the metabolite.”

Biohaven says dosing continues for all patients already randomized across the BHV-7000 program. BHV7000-303, a pivotal study in refractory focal epilepsy, is fully enrolled and randomized, it says, adding that dosing continues and topline data remain on track for later this year.

Last year, Biohaven faced FDA scrutiny and had its NDA rejected for troriluzole and its use in treating spinocerebellar ataxia, which it complained about in an 11/2025 press release (see story). An FDA complete response letter concluded that the submission failed to demonstrate substantial evidence of effectiveness.

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