Biotech Stocks Facing FDA Decision In April 2023

As we wrap up yet another month, let’s take stock of the latest regulatory news that have been dominating the headlines, and gear up for what’s ahead in April, which is observed as the National Cancer Control Month.

On March 16, the FDA granted authorization for the marketing of Copenhagen Classic Snuff, a type of loose moist snuff smokeless tobacco product manufactured by the U.S. Smokeless Tobacco Co., as a modified risk tobacco product. This action was based on the U.S. regulatory agency’s scientific review, which found that a complete switch from cigarettes to the smokeless product would lower the risk of developing lung cancer for adult smokers.

The FDA, on Mar.17, issued marketing denial orders (MDOs) for two menthol e-cigarette products marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand, as the company’s premarket tobacco product applications failed to meet the public health standards.

On March 24, the FDA released a draft guidance, with the goal of enhancing oncology clinical trials to expedite the approval process. The draft guidance focuses on the design, conduct, and analysis of data using two randomized clinical trial approaches, with the aim of both achieving accelerated approval and verifying clinical benefit.

On Mar.29, Emergent BioSolutions’ Narcan nasal spray secured the FDA nod to be switched from prescription status to over-the-counter use for opioid overdose. The approval allows for the product to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

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

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