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Biotech Stocks Facing FDA Decision In October 2022

monkeypox sept30 lt

As we enter the final quarter of the year, let's take a look at some of the regulatory news that made headlines in September.

On September 7, the FDA issued new guidance intended to support the development of more validated monkeypox tests and expand access to testing.

Since the start of the monkeypox outbreak in early May of this year through Sep.29, more than 68,000 cases have been reported worldwide, with the U.S. accounting for 25,613 cases, according to the CDC.

The FDA alerted public about the risk for squamous cell carcinoma and various lymphomas in scar tissue around breast implants on Sep.8.

The global breast implants market is expected to grow from $2.10 billion in 2021 to $2.25 billion in 2022 and reach $2.90 billion in 2026, according to ReportLinker.

Given the critical need for new treatments for rare neurodegenerative diseases, the FDA and the National Institutes of Health, on Sep.14, launched a public-private partnership to advance the knowledge of neurodegenerative diseases and promote the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases.

On Sep.29, the FDA approved Amylyx Pharmaceuticals Inc.'s (AMLX) Relyvrio to treat patients with amyotrophic lateral sclerosis, a rare disease that affects as many as 30,000 in the United States.

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

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