Articles related to FDA

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.

The FDA classified a recall of dorzolamide and timolol ophthalmic solution as a Class II event after reports of defective containers, affecting a specific lot used to treat glaucoma and ocular hypertension.

An early clinical experience report describes how one retina practice integrated photobiomodulation (PBM) for intermediate age-related macular degeneration, highlighting workflow considerations, patient selection challenges, reimbursement issues, and ongoing uncertainty regarding long-term benefit.