Biologics

FDA OKs 1st Cellular Therapy for Severe Aplastic Anemia

FDA has approved Gamida Cell’s Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia (SAA), a rare and life-threatening bone marrow disorder. The action expands the use of Omisirge to adults and children as young as six who lack a compatible stem cell donor and are eligible for reduced-intensity conditioning before transplant.

Omisirge (omidubicel-onlv) was previously approved for certain patients with blood cancers requiring hematopoietic stem cell transplant (HSCT). The new approval marks the first time a cellular therapy has been cleared specifically for SAA, a condition in which the bone marrow fails to produce adequate blood cells, according to an agency release.

Patients with SAA typically receive immunosuppressive therapy or a stem cell transplant from a matched donor, but many lack a suitable donor match. Umbilical cord blood transplants are sometimes used but can be limited by slow blood cell recovery and heightened infection risks.

Omisirge is manufactured from donated cord blood stem cells that are chemically enhanced with nicotinamide, a form of vitamin B3, to speed recovery of the blood and immune system. FDA officials say the therapy appears to overcome some limitations of traditional cord blood transplants by improving engraftment and reducing infection risks.

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