Drugs

Clinical Hold for Innate Lacutamab Trials

FDA has placed a partial clinical hold on the Innate Pharma lacutamab IND, leading to a pause in patient enrollment in the company’s Phase 2 TELLOMAK and Phase 1b PTCL trials in cutaneous and peripheral T-cell lymphoma. A company statement says the hold follows one fatal case of hemophagocytic lymphohistiocytosis.

Lacutamab is described as a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is in clinical trials to treat cutaneous T-cell lymphoma and peripheral T-cell lymphoma.

FDA has granted the drug fast-track designation to treat patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. The agency also granted it orphan drug status to treat cutaneous T-cell lymphoma.

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