Biotech Stocks Facing FDA Decision In November 2021

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It's that time of month again when we take a look back at some of the regulatory news of October and look ahead to what's on the horizon for November.

On October 8, the FDA approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic, developed by Enzyvant, is the first and only treatment approved in the U.S. for this condition.

In a first, the FDA authorized the marketing of tobacco-flavored 3 e-cigarette products of R.J. Reynolds under the brand name Vuse on Oct.12. While the FDA says that the approval could benefit addicted adult smokers who switch to these products - either completely or with a significant reduction in cigarette consumption - by reducing their exposure to harmful carcinogens, anti-smoking advocates have a different view.

Earlier in the month, the FDA warned public and health care providers not to use needle-free injection devices for fillers, which have not been approved. Marketed as Hyaluron Pens, Hyla-Pen, microinjectors, noninvasive injection pens, noninvasive nebulizer syringes, high pressure pens or sprayer pens, these needle-free devices could cause permanent damage to the skin, lips and eyes.

A landmark proposal to establish a new category of over-the-counter (OTC) hearing aids was issued by the FDA on October 19. When finalized, the rule would help improve access to and reduce the cost of hearing aid technology for millions of Americans.

In order to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions, the FDA, on October 27, said it is restricting the sale and distribution of breast implants only to healthcare providers. The regulatory agency also called for adding boxed warnings and a new checklist of risks for patients to review in the products' label.

Let's take a look at the biotech stocks facing FDA decision in November.

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