The week of August 15 to 21, 2024, saw a flurry of regulatory activity and public health mobilization, highlighting significant progress in both pharmaceutical development and disease prevention. In the United States, the Food and Drug Administration (FDA) pushed forward on several major drug decisions, marking an intense period of high-priority reviews.
Leading the charge was midomafetamine (commonly known as MDMA), a psychedelic compound being explored as a breakthrough treatment for post-traumatic stress disorder (PTSD). The FDA continued its evaluation following the Prescription Drug User Fee Act (PDUFA) date of August 11, suggesting a decision may be imminent. If approved, this could mark a historic moment in the integration of psychedelic-assisted therapy into mainstream mental health treatment.
Another notable candidate on the FDA’s docket was linvoseltamab, developed for patients suffering from relapsed or refractory multiple myeloma. This biologic therapy is designed to address one of the most challenging forms of blood cancer, with a decision on its Biologics License Application expected by August 22. The FDA’s rapid progress reflects an urgency to deliver novel treatments to patients with limited options.
In addition to these high-profile evaluations, the FDA approved seven new drugs throughout August. Among them was the Rybrevant and Lazcluze combination from Johnson & Johnson, indicated for non–small-cell lung cancer patients with EGFR mutations. The month’s list of approvals also included three new biologics and several small molecule drugs, indicating a robust and diverse expansion in therapeutic options across multiple disease areas.
Meanwhile, in Africa, health authorities intensified efforts to curb the spread of mpox (formerly known as monkeypox), as cases continued to rise in several regions. The Africa Centres for Disease Control and Prevention (Africa CDC) prepared to distribute mpox vaccines in countries such as the Democratic Republic of the Congo and Uganda by August 20. The proactive approach underscores the continent’s growing capacity to respond swiftly to viral outbreaks.
International support bolstered these efforts. The World Health Organization (WHO) unveiled a comprehensive strategic preparedness and response plan on August 26. This included Germany’s donation of 100,000 vaccine doses and emphasized the need for enhanced global cooperation. Additionally, the United Nations’ International Organization for Migration (IOM) issued an appeal for $18.5 million to aid regions most affected by the outbreak.
Together, these developments illustrate a pivotal week in global health, where the swift advancement of medical treatments in the U.S. paralleled escalating international measures to combat infectious disease threats.
