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Biotech Stocks Facing FDA Decision In July 2021

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As June draws to a close, it's time to take a look back at some of the month's top news stories related to FDA approval and look ahead to what July has in store.

A number of firsts occurred in June on the regulatory front.

ProMetic Biotherapeutics' Ryplazim was greenlighted by the FDA on June 4, becoming the first treatment for patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can impair normal tissue and organ function and may lead to blindness.

On June 17, Bayer Healthcare's Astepro, a nasal antihistamine, was approved for seasonal and perennial allergic rhinitis - commonly known as allergies. The approval is a first-in-class and was enabled by the prescription to nonprescription switch process.

Boehringer Ingelheim's Pradaxa secured the regulatory nod on June 21, to become the first oral blood thinning medication for children.

One of the controversial decisions by the FDA in recent times is the accelerated approval of Biogen's Aduhelm for the treatment of Alzheimer's on June 7, despite an advisory committee recommending against its approval. Aduhelm, the first new drug for Alzheimer's in 20 years, carries a price tag of $56,000 per year.

Now, let's take a look at the biotech stocks facing FDA decision in July 2021.

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