FDA News

Your daily dose of the clinical news you may have missed.

The Loss of Pulse Detection feature will begin rolling out in the US late next month.

Your daily dose of the clinical news you may have missed.

The FDA accepted the sNDA for risperidone (Uzedy) extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults.

Your daily dose of the clinical news you may have missed.

The FDA has set a PDUFA target action date for October 13, 2025, according to Arcutis Biotherapeutics.

Investigators reported that roflumilast cream 0.05% significantly reduced AD severity as early as Week 1, with a notable effect on pruritus seen in as little as 24 hours.

The Metrix COVID/Flu molecular test detects and differentiates SARS-CoV-2, influenza A, and influenza B in approximately 20 minutes.

These label changes to Sublocade from Indivior mark a significant advancement in the management of moderate to severe opioid use disorder.

The clearance enables Alphyn to initiate global phase 2b clinical trials, which are anticipated to begin in the first quarter of 2025.