Articles related to FDA

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.

The FDA approved a low-estrogen weekly contraceptive patch for pregnancy prevention in eligible women with BMI below 30 kg/m². Approval was supported by Phase 3 efficacy, safety, and adhesion data, but use remains subject to established combined hormonal contraceptive contraindications.

The FDA approved Furoscix ReadyFlow, a subcutaneous furosemide autoinjector for edema associated with heart failure or chronic kidney disease. Clinical data demonstrated pharmacokinetic exposure and diuretic effects comparable to intravenous furosemide.

The FDA approved Lytenava as the first ophthalmic bevacizumab formulation for wet AMD. The decision moves bevacizumab beyond repackaged intravenous use, with launch logistics still pending.

The FDA issued a Class II recall for an amphetamine-based ADHD medication after a labeling mix-up resulted in immediate-release capsules being packaged as extended release. The recall affects a single lot totaling 1,392 bottles.