KENILWORTH (NJ) (dpa-AFX) - As January 2026 comes to a close, it is time to reflect on the regulatory developments of the month and look ahead to what's in store in February.
On January 13, 2026, Sentynl Therapeutics' Zycubo secured FDA approval, becoming the first treatment for pediatric patients with Menkes disease, a rare neurodegenerative disorder caused by a genetic defect that impairs the body's ability to absorb copper.
Food labelling also took center stage this month. In a bid to improve gluten ingredient disclosure in foods, the U.S. regulator issued a Request for Information (RFI) on January 21, 2026, regarding labelling and preventing cross-contact of gluten in packaged food. The FDA is seeking detailed input on issues including the prevalence of products in which rye or barley are not currently disclosed, the severity and potency of immunoglobulin E-mediated allergies to rye and barley, and concerns around gluten content in oats due to cross-contact, among other related topics.
Looking ahead on the regulatory front, several drugs are scheduled for FDA review this February. Will they pass the regulatory muster, or will they be sent back to the drawing board?
Let's take a look at the biotech stocks facing the FDA decision in February 2026.
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