Drugs

Orphan Status for Minovia Myelodysplastic Drug

FDA has granted Minovia Therapeutics an orphan drug designation for its lead investigational therapy, MNV-201, for myelodysplastic syndrome (MDS). MNV-201 is described by the company as a first-in-class mitochondrial cell therapy that uses Minovia’s Mitochondrial Augmentation Technology to introduce healthy mitochondria into a patient’s stem cells, aiming to restore cellular function. Early-stage studies in Pearson Syndrome patients have shown a favorable safety profile and signs of multi-system benefit, including improved hematologic stability and quality of life, the company says.

MDS is a serious age-related blood disorder characterized by ineffective hematopoiesis and a risk of progression to acute myeloid leukemia, according to Minovia. The median age at diagnosis is about 70, and the disease carries a high symptom burden and risk of mortality, it says. The company is currently conducting a Phase 1b study in low-risk MDS patients, with six of nine planned patients already dosed.

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