Drugs

Drug Quality Assurance Inspections Up in 2025

The FDA FY 2025 Report on the State of Pharmaceutical Quality shows that in FY 2025, there were 1,248 drug quality assurance inspections, up from 972 such inspections in FY 2024. Of the 1,248 drug quality inspections, 432 (44%) were in the U.S., and 540 (56%) were in foreign countries.

At the end of FY 2025, the report says, CDER’s Site Catalog included 5,953 manufacturing sites globally, with 57% of them located in the U.S.

CDER’s Product Catalog contained 422 BLAs, including 82 biosimilar products, a 30% increase from the 63 biosimilar products at the end of FY 2024.

The report says that BLAs have increased from 2.3% of all approvals in FY 2016 to 4.8% in FY 2025, with biosimilars representing 42% of the approved BLAs in FY 2025, up from 17% in 2016.

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