FDA Activity Round Up – July 2026

• Gilead Sciences has successfully won a legal case regarding its HIV medication, securing a favorable ruling for the company. • Eli Lilly announced plans to expand patient access to retatrutide, a promising weight-loss and metabolic drug currently in development.

• Two people in Michigan have died following a cyclospora outbreak, marking the first confirmed fatalities related to the microscopic parasite in the United States. • State health officials noted that while cyclosporiasis is rarely life-threatening, these deaths involved individuals with significant underlying health conditions.

• Researcher Eric Verdin is studying experimental drugs, specifically GLP-1 medications, to determine if they can extend human life and mimic the benefits of calorie restriction. • While calorie restriction is known to improve lifespan and reduce age-related diseases, many individuals struggle to maintain the strict diets required to achieve these results.

• Pharmacy Times and the American College of Physicians have introduced new digital tools, including a dedicated iPad app for the internal medicine journal. • The Annals of Internal Medicine app provides practitioners with research, guidelines, and access to 12 months of archived journal issues.

• Since the initial reporting of the novel coronavirus, medical understanding of Covid-19 has evolved significantly regarding transmission and prevention. • In December 2020, the US FDA granted emergency use authorization to Pfizer/BioNTech and Moderna vaccines after clinical trials showed over 90% effectiveness.

• Researchers have discovered that genetic factors may determine why certain individuals suffer more significant brain damage from chronic sleep deprivation than others. • A preliminary study suggests that the lycopene and antioxidants in tomatoes may reduce oxidative stress and improve liver fat metabolism in people with MASLD.

• Betting platforms Kalshi and Polymarket now allow users to wager on whether the FDA will approve treatments for lung, breast, pancreas, and blood cancers this year. • Kalshi intends to expand its offerings by allowing users to bet on the specific outcomes of clinical drug trials.

• Since the initial reporting of Covid-19, medical understanding has evolved significantly regarding the virus's behavior and the effectiveness of countermeasures. • In December 2020, the US FDA granted emergency use authorization to Pfizer/BioNTech and Moderna vaccines after clinical trials demonstrated over 90% efficacy in preventing symptomatic disease.

• The FDA is currently reviewing Moderna's mRNA-based flu vaccine, which would be the first of its kind to enter the commercial market. • This decision comes amid a climate of skepticism regarding mRNA technology, highlighted by questions from RFK Jr. and recent HHS funding cuts.

• The Department of Veterans Affairs is launching a randomized clinical trial to determine if GLP-1 drugs can reduce alcohol abuse among U.S. military veterans. • The study will specifically measure whether semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, can decrease drinking and improve overall quality of life.

• Helus Pharma has appointed a new CEO to lead the company as it advances its lead candidate, HLP003, toward potential commercialization. • The company announced that enrollment is now complete for the APPROACH clinical trial, with topline data expected to be released in Q4 2026.