FDA News

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Mineralys Therapeutics also expects topline data from its phase 2 study of lorundrostat for the treatment of uncontrolled hypertension or resistant hypertension when used as an add-on therapy.

The agency estimates that limiting nicotine levels could lead to 1.8 million fewer tobacco-related deaths by 2060 and health care savings of $1.1 trillion a year over the next 40 years.

Marketed as Omvoh, the therapy is already approved as a first-in-class treatment for moderately to severely active ulcerative colitis.

Early proof-of-concept phase 1a data from the trial is anticipated in the third quarter of 2025.

FDA action date set for July 26, 2025.

Weekly SC injection of lecanemab is expected to maintain clinical and biomarker benefits reached during the IV initiation phase. The PDUFA date is Aug 31, 2025.

If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.

The acquisition brings lumateperone, known as Caplyta, and the clinical-stage agent ITI-1284, for generalized anxiety disorder and Alzheimer's agitation, into the J&J fold.

The planned Phase 2 trial in IPF will focus on assessing MTX-463’s safety, pharmacokinetics, and efficacy.