Fda

The long-stagnant primary biliary cholangitis drug market has seen renewed attention in the past 3 months with the addition of two FDA-approved therapy options as well as a costly ruling from an FDA advisory committee.

FDA black box warnings about antidepressants for pediatric patients — meant to decrease suicidal thoughts and behavior — may have had the opposite effect, according to a systematic review.

The FDA has approved the supplemental new drug application for Ameluz topical gel 10% to increase the maximal dosage from one to three tubes per treatment of actinic keratosis, according to a Biofrontera press release.

The first over-the-counter monograph order request tier 1 application for bemotrizinol, an active sunscreen ingredient, has been submitted to the FDA, dsm-firmenich announced in a press release.

The FDA has granted investigational device exemption to a clinical-stage health care firm for its proprietary neuroimmune modulation platform for individuals with relapsing-remitting MS, according to the manufacturer.

Nvision Biomedical Technologies announced FDA clearance of its 3D-printed PEEK interbody system made from PEEK-OPTIMA polymers from Invibio Biomaterial Solutions, according to a company press release.

The FDA approved Exact Sciences’ Cologuard Plus multitarget stool DNA test to screen adults aged 45 years or older at average risk for colorectal cancer, according to a company press release.

Obscured by the celebratory congratulations and profuse praise of the scientific advance marked by the FDA’s approval of KarXT, now branded Cobenfy, is the revealing and instructive story of how this novel therapeutic agent came to fruition.

The FDA expanded the approval of nivolumab for treatment of non-small cell lung cancer.

Shortages of tirzepatide, a GIP/GLP-1 dual agonist approved for the treatment of type 2 diabetes and obesity, have been resolved, the FDA announced.