Articles related to FDA

The FDA warned that counterfeit over-the-counter eye drops found in several states may contain bacterial contamination capable of causing serious ocular infections. No associated adverse events had been reported when the warning was issued.

The FDA approved RayOne Galaxy and RayOne Galaxy Toric for US commercial availability following a multicenter IDE study of more than 250 patients, expanding presbyopia-correcting IOL options for cataract surgeons.

The FDA classified a recall of thyroid tablets USP 30 mg as Class I after identification of a superpotent product lot. The recall affects 1,955 bottles and carries risk of serious adverse health consequences, making prompt inventory review and product removal necessary.

The FDA approved updated 2026-2027 formulations of Pfizer-BioNTech, Moderna, and Novavax COVID-19 vaccines targeting the XFG variant, aligning with advisory committee recommendations for the upcoming vaccination season.

The FDA granted Breakthrough Therapy designation to DT120, an oral lysergide formulation under investigation for major depressive disorder, based on phase 3 findings suggesting rapid and sustained antidepressant effects, though the treatment remains investigational and unapproved.

The FDA authorized Avulux lenses as a nonpharmacologic adjunct for migraine-associated light sensitivity in patients aged 12 years and older, supported by clinical data showing reduced photophobia and exploratory signals of headache pain improvement in some users.