2 Minute Medicine: Pharma Roundup: Enbumyst Nasal Spray Approval, FDA Targets Drug Ads, Samsung BioLogics Contract, Wegovy Mental Health Benefits [September 17 2025]

Corstasis’ Enbumyst nasal spray approved for edema
The Food and Drug Administration has approved Enbumyst, a bumetanide nasal spray, for adults with edema linked to congestive heart failure, chronic kidney disease, and liver disease, making it the first intranasal loop diuretic to reach the U.S. market. More than 6.7 million Americans live with heart failure, and fluid overload drives over one million hospitalizations each year, highlighting the potential impact of a more convenient delivery route. In pivotal studies, the spray produced natriuresis comparable to intravenous bumetanide within two hours, while oral absorption varied by more than 40 percent. Corstasis expects to launch later this year and is projecting multi-billion dollar annual sales. Trial data showed the most common adverse events were dizziness, hypovolemia, and nausea, consistent with the loop diuretic class. For clinicians, the key appeal may be the ability to manage patients who otherwise oscillate between oral failure and hospitalization. This approval reflects how rethinking delivery methods can shift a drug’s role in daily practice.

FDA escalates warning letters over misleading drug advertising
The FDA announced on September 9 that it had issued thousands of warning letters and about one hundred cease and desist orders targeting pharmaceutical ads that regulators deemed misleading. Among the ads flagged were campaigns for weight-loss drugs such as Mounjaro and Zepbound, some of which aired during an Oprah Winfrey special that failed to include adequate safety information. Until this month, enforcement had been nearly dormant, with no letters issued in 2024 and only one in 2023. The agency suggested that new formal advertising rules could follow, adding pressure to an industry that spends more than six billion dollars annually on direct-to-consumer promotion. For physicians, the result may be patients arriving with different expectations, shaped less by glossy marketing and more by transparent discussion of risks. This crackdown signals a new regulatory posture, one that could reshape how pharma communicates with the public.

Samsung BioLogics lands $1.3 billion U.S. contract amid tariff uncertainty
Samsung BioLogics has signed a contract worth about 1.8 trillion won, equal to 1.3 billion U.S. dollars, with an American pharmaceutical company under terms that run through 2029. The company already operates 784,000 liters of biologics capacity and has pledged to expand to nearly one million liters by 2027, solidifying its status as the world’s largest contract biologics manufacturer. Industry analysts believe the undisclosed partner is a top ten U.S. firm, a sign of how global players are securing capacity in advance of possible trade disruptions. The contract underscores the double-digit growth of the contract development and manufacturing market, which has become central to pharma’s risk-management strategy. While clinicians may not feel the effects directly, these long-term supply commitments ultimately influence how reliably advanced therapies reach patients. This deal illustrates how production security is becoming as important as clinical innovation.

Wegovy survey finds decline in constant food thoughts and improved well being
A survey of 550 adults presented at the European Association for the Study of Diabetes found that the proportion reporting constant food thoughts dropped from 62 percent to 16 percent after treatment with Wegovy, representing a 46 percent relative reduction. In the same study, 64 percent of participants said their overall mental well being improved. Novo Nordisk, which generated more than five billion dollars in Wegovy sales last year, is presenting these findings as evidence that obesity treatment should also be viewed through a psychological lens. Most of the participants were middle aged women, so further study will be needed to see if benefits extend broadly across populations. Still, the idea of reducing “food noise” resonates with many patients who describe the condition as both a metabolic and cognitive burden. For physicians, the survey offers another angle when counseling patients on the benefits of therapy: weight loss, yes, but also a quieter mind.

Image: PD

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