Biotech Stocks Facing FDA Decision In November 2023

(RTTNews) - As we bid farewell to another month, it's time to take a look back at some of the regulatory developments that took center stage in October and take a glimpse into what lies ahead in the month of November.

An updated version of Novavax COVID-19 vaccine was authorised by the FDA on Oct.3, 2023, just two weeks following the approval of updated vaccines from Pfizer-BioNTech and Moderna. These vaccines are designed to enhance protection against currently circulating variants of the SARS-CoV-2 virus.

On Oct.11, the FDA announced the creation of a Digital Health Advisory Committee, with the aim of assisting the agency in navigating intricate scientific and technical matters associated with digital health technologies (DHTs), which encompass artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software.

The FDA issued marketing denial orders to R.J. Reynolds Vapor Company, on Oct.12, disallowing the marketing of six flavored e-cigarette products within its Vuse Alto brand due to their failure to meet public health standards.

Servier Pharmaceuticals' Tibsovo received the FDA nod for the treatment relapsed or refractory myelodysplastic syndromes with an isocitrate dehydrogenase-1 (IDH1) mutation on Oct.24. This marks the first approval of a targeted therapy for this specific indication.

Now, let's take a look at the pharma companies awaiting word from the FDA in November.