Drugs

Novo Nordisk’s High-Dose Wegovy Approved

FDA has approved a higher-dose version of Novo Nordisk’s blockbuster weight-loss drug Wegovy (semaglutide) injection, marking the fourth product cleared under the agency’s fast-track National Priority Voucher Program. The new formulation, Wegovy HD (7.2 mg), is indicated for chronic weight management in adults with obesity, or those who are overweight with at least one weight-related condition. The drug is also approved for long-term weight maintenance. Regulators completed the review in just 54 days, underscoring the agency’s push to accelerate approvals tied to national health priorities, according to an agency release.

“This approval demonstrates what the FDA can accomplish when we try bold new things,” FDA commissioner Marty Makary said, highlighting the agency’s emphasis on speed and efficiency under the pilot voucher program.

Wegovy belongs to a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists, which help regulate appetite and blood sugar. According to FDA, clinical data showed that the higher dose delivered greater average weight loss compared to previously approved doses, while maintaining a safety profile consistent with semaglutide’s known effects. Among patients with both obesity and Type 2 diabetes, the higher dose produced similar reductions in blood sugar levels, as measured by hemoglobin A1C.

However, the agency flagged several safety considerations. The most common side effects were gastrointestinal, including nausea, vomiting, diarrhea, constipation, and abdominal pain. Patients receiving the higher dose also reported increased instances of altered skin sensations — such as burning or sensitivity — which typically resolved on their own or with dose adjustments. FDA said it is continuing to investigate this reaction.

Like other semaglutide products, Wegovy carries a Boxed Warning about a potential risk of thyroid C-cell tumors, based on findings in animal studies. It is not recommended for patients with a personal or family history of medullary thyroid carcinoma or those with Multiple Endocrine Neoplasia syndrome Type 2.

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

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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