FDA News

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.

Merilog joins two long-acting insulin biosimilar products approved in 2021, bringing the total to three insulin biosimilars available in the United States.

The development comes at a time when cannabis use disorder has risen steadily in the United States.

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Rezpegaldesleukin targets the IL-2 receptor complex to stimulate regulatory T cells, aiming to restore immune balance in people with atopic dermatitis.

The FDA set a PDUFA action date of December 12, 2025 for lerodalcibep, according to LIB Therapeutics.

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The novel therapy combines aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor.