Novo Nordisk, Hims & Hers & FDA Updates: Wegovy, Ozempic & Drug Safety News
- The market for obesity and weight-loss medications is becoming increasingly competitive, with legal battles and regulatory scrutiny intensifying.
- On February 9, 2026, Novo Nordisk filed a federal lawsuit against Hims & Hers, alleging patent infringement related to the sale of compounded versions of Wegovy and Ozempic.
- Compounding pharmacies create customized medications based on prescriptions from healthcare providers, often used when commercially available drugs are in short supply or require specific formulations.
The market for obesity and weight-loss medications is becoming increasingly competitive, with legal battles and regulatory scrutiny intensifying. Novo Nordisk, the manufacturer of the popular drugs Wegovy and Ozempic, is taking aggressive steps to protect its market share, including a lawsuit against telehealth provider Hims & Hers and a dispute with the Food and Drug Administration (FDA) over advertising claims.
Legal Action Against Hims & Hers
On , Novo Nordisk filed a federal lawsuit against Hims & Hers, alleging patent infringement related to the sale of compounded versions of Wegovy and Ozempic. The lawsuit claims that Hims & Hers is unlawfully marketing unapproved, custom-made versions of these drugs, circumventing the FDA’s rigorous safety review process. Novo Nordisk estimates that approximately 1.5 million Americans are currently using compounded versions of its medications.
Compounding pharmacies create customized medications based on prescriptions from healthcare providers, often used when commercially available drugs are in short supply or require specific formulations. While the FDA permits compounding under certain circumstances – such as drug shortages or personalized patient needs – Novo Nordisk argues that the continued availability of compounded versions of its drugs, even after they were removed from the FDA shortage list in early 2025, is problematic. The company contends that these compounded drugs haven’t undergone the same level of safety and efficacy testing as its FDA-approved products.
Hims & Hers responded to the lawsuit, characterizing it as an attack on consumers who rely on compounded medications and an attempt to limit patient choice. The company had previously announced plans to sell a cheaper, compounded version of Wegovy for as little as $49 per month, significantly lower than the price offered through NovoCare, Novo Nordisk’s direct-to-consumer platform. However, Hims & Hers ultimately decided to halt those plans following pressure from Novo Nordisk and the FDA.
FDA Concerns and Advertising Disputes
The FDA’s involvement extends beyond the Hims & Hers situation. The agency issued a warning letter to MedisourceRx, a compounding pharmacy owned by Hims & Hers, late in , citing troubling problems discovered during a facility inspection. Details of the inspection findings were not immediately available.
the FDA has taken issue with Novo Nordisk’s own marketing practices. The agency determined that a television advertisement for Wegovy contained “false or misleading” claims about the drug’s abilities and benefits. The specifics of these misleading claims were not detailed in available reports.
Broader Pharmaceutical Developments
These developments occur alongside other significant events in the pharmaceutical landscape. The FDA recently rejected Regenxbio’s gene therapy, RGX-121, for the rare disease mucopolysaccharidosis type II (Hunter syndrome). This one-time treatment aimed to replace a malfunctioning gene responsible for the disorder.
In cardiovascular health, a new analysis suggests that the adverse event labels on statin medications may be overly cautious. A pooled analysis of clinical trial data indicated that only a small number of side effects currently listed on statin labels have strong evidence supporting a causal link to the drug. The Cholesterol Treatment Trialists’ (CTT) Collaboration published these findings in in The Lancet.
The National Cancer Institute (NCI) is also exploring the potential of ivermectin as a cancer treatment. NCI Director Anthony Letai stated that preliminary studies have shown ivermectin’s “ability to kill cancer cells,” prompting further investigation. This is notable given the controversial history of ivermectin as a treatment for COVID-19.
Finally, research on cervical cancer screening suggests that most U.S. Women prefer in-clinic testing to at-home sample collection. A separate analysis indicates that less frequent screening intervals may be beneficial for women in Norway, particularly those vaccinated against the human papillomavirus (HPV).
The ongoing developments highlight the complex interplay between pharmaceutical innovation, regulatory oversight, market competition and patient access. The legal and regulatory challenges faced by Novo Nordisk underscore the increasing scrutiny surrounding the rapidly expanding market for obesity and weight-loss medications, and the importance of ensuring both patient safety and access to effective treatments.