Drugs

Woodcock Joins Friends of Cancer Research Board

Patient advocacy group Friends of Cancer Research has added former principal deputy commissioner Janet Woodcock to its board of directors. Woodcock retired late 2023 after 37 years at the agency (see earlier story). She spent over two decades as CDER director until the Covid-19 pandemic saw her move to the government’s “Operation Warp Speed” response in early 2020. In this capacity, she supported the development, evaluation, and availability of treatments such as monoclonal antibodies and antiviral drugs for patients with Covid-19.

The group also added Kendall Square Policy Strategies principal Paul Kim to the board. Previously, Kim was head of the FDA and federal government strategies practices at Foley Hoag for 20 years. Earlier in his career, Kim served as counsel to the late Senator Edward Kennedy (D-MA).

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