FDA News

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.

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

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.

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

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

The FDA has set the Prescription Drug User Fee Act target action date for bronchiectasis for August 12, 2025, Insmed Incorporated announced.

Onapgo is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in people with advanced Parkinson disease.

Hardware or software changes as well as user adjustments may disable or mute alerts for elevated glycemia, medication use, and other diabetes management essentials, the agency said.