Articles related to FDA

The FDA classified a recall of 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief as a Class II event after the manufacturer identified sterility concerns and potential contamination affecting a single lot.

The FDA approved Moderna’s mFLUSIVA, the first mRNA influenza vaccine, for adults aged 50 and older. Availability is expected during the 2026–2027 respiratory virus season, with confirmatory evidence pending for adults 65 and older.

The FDA accepted Belite Bio’s NDA for tinlarebant in Stargardt disease type 1 and granted Priority Review. In the phase 3 DRAGON trial, treatment reduced atrophic retinal lesion growth by 35.7% compared with placebo, with regulatory review ongoing.

The FDA classified a voluntary nationwide recall involving nearly 12 million cartons of Rohto Cooling Eye Drops after a lack of assurance of sterility was identified. The action was designated a Class II recall, indicating medically reversible risks or a remote probability of serious harm.

The FDA approved Freenome’s SimpleScreen CRC blood test for colorectal cancer screening in average-risk adults. Clinical study results showed the test detected roughly 80% of colorectal cancers, though current guidelines continue to favor colonoscopy and stool-based screening options.

The FDA expanded the indication for olopatadine hydrochloride and mometasone furoate nasal spray to include children aged 6 to younger than 12 years with seasonal allergic rhinitis. Approval was supported by a phase 3 trial demonstrating improved nasal symptoms versus placebo.