Drugs

Generic Mifepristone Maker Wants to Defend Suit

GenBioPro, which manufactures a generic form of the abortion medication mifepristone, has petitioned a Texas federal court to be added to the defendants in the first legal fight over the procedure since Donald Trump became president again. The Hill reports that Missouri et. al. v FDA is a revamped version of a 2023 suit filed by anti-abortion groups and doctors seeking to block FDA’s approval of the abortion drug.

The states that filed the suit want FDA to ban telehealth prescriptions for mifepristone, ban its use after seven weeks of pregnancy, and prevent pharmacies from dispensing it, the article says.

“We remain concerned about extremists and special interests’ attempts to undermine FDA’s regulatory authority,” GenBioPro CEO Evan Masingill said in a statement. FDA approved GenBioPro’s generic version in 2019.

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