Biologics

Calidi Bio Gets Fast Track for Sarcoma Therapy

FDA has granted Calidi Biotherapeutics fast-track status for CLD-201, an allogeneic stem-cell-loaded oncolytic virus being developed to treat soft tissue sarcoma. The therapy uses adipose-derived mesenchymal stem cells loaded with an oncolytic vaccinia virus to deliver therapy directly to tumor sites, according to the company. This strategy is intended to shield the virus from the immune system, enhance its replication, and amplify immune activation, an approach that has demonstrated promising results in preclinical studies, it says.

Calidi says it is planning a Phase 1 trial to evaluate the safety, tolerability, and preliminary efficacy of CLD-201 in patients with soft tissue sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.

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