Biologics

CBER Approved 67 Products in 2024: Report

CBER director Peter Marks’ annual report for 2024 says the Center approved 24 biological devices, 17 BLAs, and 26 BLA supplements in 2024. The report also says CBER continued its focus on facilitating the development of cell and gene therapies through numerous public town halls, Webinars, and a workshop, along with the publication of several guidances.

“In addition to the portfolio of product approvals this year,” the report says, “CBER continued its patient engagement efforts with a focus on gene therapy and rare diseases.”

Safety Communications issued by the Center in 2024 dealt with amniotic fluid eyedrops, a required Boxed Warning for T cell malignancies following treatment with BCMA-directed or CD-19 directed autologous CAR T cell immunotherapies, use of unapproved HIV blood sample self-collection kits, and modifications to the Risk Evaluation and Mitigation Strategy for the CAR T cell immunotherapies.

The report also discusses research to address challenges in the development and regulatory evaluation of medical products, increased preparedness for emerging threats and promoting global public health, and managing for strategic excellence and organizational accountability.

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