Recent and anticipated novel drug approvals (1Q 2026 through 4Q 2026) | American Journal of Health-System Pharmacy

• Two new reports, including one from the CDC's Morbidity and Mortality Weekly Report, analyze the difficulties in containing recent measles outbreaks within the U.S. • The studies focus on a major outbreak that began on October 2, 2025, in Spartanburg County, South Carolina, marking the largest U.S. outbreak since the disease was declared eliminated in 2000.

• WHO Director-General Tedros Adhanom Ghebreyesus announced that clinical trials for two experimental drugs will launch next week in the Democratic Republic of the Congo. • The trials will evaluate whether the antivirals MBP134 and remdesivir, provided via donations from the United States and Gilead Sciences, can reduce mortality rates.

• JAMA Network Open has published a taxpayer-funded study on COVID-19 vaccines that federal officials at the CDC previously declined to release. • The study examines vaccine efficacy and safety, raising questions about why the CDC initially squelched the data and whether the decision was based on political motivations or a desire to protect public confidence.

• HHS Secretary Robert F. Kennedy Jr. stated on Monday that the United States must reclaim its position as the global leader in medical research and innovation. • Kennedy highlighted a competitive gap, noting that China is currently conducting more early-stage clinical trials than the U.S.

• Allies of HHS Secretary Robert F. Kennedy Jr. are working to embed his vaccine agenda within institutions by influencing research priorities and policy translation, despite ongoing legal and political challenges. • New York health officials have accused Tiger Medical Holdings of "smuggling" alloClae, a popular injectable filler derived from human fat, into the state.

• A study examining COVID-19 vaccine effectiveness was finally published after being blocked from inclusion in a weekly federal government report by the CDC. • The publication follows a separate effort by Robert F. Kennedy Jr., who petitioned the FDA to revoke the authorization of all COVID-19 vaccines.

• The Trump administration announced a multi-pronged initiative on Monday aimed at strengthening the early clinical trial ecosystem within the United States. • As part of this effort, the FDA will reconsider Regenxbio’s gene therapy designed to treat Hunter syndrome, a rare pediatric disease.

• A study confirming the effectiveness of COVID-19 vaccines was published Tuesday by JAMA Network Open after being blocked by a CDC journal. • The research found the vaccine was approximately 55% effective against hospitalizations and reduced emergency department and urgent care visits by 50%.

• The U.S. Department of Health and Human Services (HHS) and the FDA have launched an "unprecedented" initiative to restore American leadership in clinical trials and counter competition from China. • A key component of the plan is an expedited investigational new drug pilot program designed to reduce early trial timelines by as much as 12 months.

• The National Association of County and City Health Officials (NACCHO), representing over 3,300 local health departments, released new research on public health preparedness and response capacities. • Findings indicate that over half of local health departments feel completely prepared to handle small-scale infectious disease outbreaks (59%), pandemics (57%), and vaccine-preventable diseases (53%).

FDA's early-stage clinical trial program, a mysterious single patient gets retatrutide access, and more health news from Morning Rounds

• As of June 18, 2026, a measles outbreak in the U.S. has reached 2,104 confirmed cases across 41 different jurisdictions. • The CDC has issued a warning that increased summer travel may accelerate the spread of the virus, posing a significant risk to families.