THOUSAND OAKS (dpa-AFX) - Every year, the month of June is observed as the
Alzheimer's and Brain Awareness Month, a time dedicated to raising awareness and
fostering conversations about Alzheimer's disease and other forms of dementia.
Notably, in June, Eli Lilly's investigational antibody therapy Donanemab for
treating early Alzheimer's will be reviewed by an advisory panel.

Before delving into the drugs awaiting FDA decision in June, let's recap some
regulatory events that occurred in May.

On May 1, a Memorandum of Understanding was established by the FDA and the U.S.
Department of Agriculture (USDA) to Clarify Roles and Responsibilities for
Regulation of Intentional Genomic Alterations (IGAs) in Animals. The IGAs in
animals can be made using modern molecular technologies, and these technologies
are said to hold great promise for various applications, including animal
disease resistance, controlling disease transmission, and enhancing food
production.

On May 16, the FDA approved Amgen's Imdelltra, the first and only T-cell engager
therapy for the treatment of extensive-stage small cell lung cancer.

On May 28, the FDA approved Amgen's Bkemv as the first interchangeable
biosimilar to Soliris to treat paroxysmal nocturnal hemoblobinuria and atypical
hemolytic uremic syndrome. This marks the 53rd approved biosimilar in the U.S.,
with 13 designated as interchangeable.

Now, let's take a look at the biotech stocks awaiting FDA decision in June 2024.



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