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Biotech Stocks Facing FDA Decision In April 2024

World Health Day, observed annually on April 7th, provides an opportunity to focus on key public health issues. This date also commemorates the founding anniversary of the World Health Organization (WHO) in 1948. The theme for World Health Day 2024 is ‘My health, my right’, which underscores the significance of individual health empowerment.

Meanwhile, the month of March saw several notable milestones with regards to FDA approvals.

On Mar.21, 2024, the FDA approved Italfarmaco’s Duvyzat, which marks the first nonsteroidal drug to treat patients with all genetic variants of Duchenne Muscular Dystrophy (DMD).

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The first gene therapy for children with metachromatic leukodystrophy, Lenmeldy, developed by Orchard Therapeutics was greenlighted by the U.S. regulatory agency on Mar.18, 2024.

On Mar.14, 2024, Madrigal Pharma’s Rezdiffra received the FDA nod, becoming the first treatment for adults with noncirrhotic NASH (also called MASH).

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

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