Biotech Stocks Facing FDA Decision In September 2021

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As August draws to a close, let us take a look back at some of the regulatory headlines from that eventful month and look forward to what September has in store.

A new treatment for Pompe disease, Sanofi's Nexviazyme, was approved by the FDA on Aug.6. The company already has one approved Pompe disease drug, which is sold as Myozyme in Europe and Lumizyme in the U.S.

The U.S. regulator approved a novel indication for Xywav for idiopathic hypersomnia (IH) in adults on Aug.12. This drug is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

On Aug.23, Pfizer-BioNTech COVID-19 Vaccine became the first to receive full FDA approval for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will now be marketed as Comirnaty and will also continue to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

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

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