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This announcement regarding the new sNDA for roflumilast cream in pediatric patients with psoriasis follows positive findings from the MUSE study.

Arcutis Submits sNDA for Roflumilast Cream 0.3% for Psoriasis in Children Aged 2-5 Years

The FDA has approved the therapy, marketed as Wayrilz, a new treatment for chronic immune thrombocytopenia.

FDA Approves BTK Inhibitor Rilzabrutinib for Immune Thrombocytopenia

FDA approval of weekly subcutaneous lecanemab-irmb offers at-home maintenance therapy for early Alzheimer’s after initial intravenous treatment.

FDA Approves Subcutaneous Lecanemab-irmb (LEQEMBI) for Early Alzheimer Disease

This FDA News Month in Review provides a round-up of regulatory decisions from August 2025.

8 FDA Headlines You Missed in August 2025

Outlook Therapeutics has expressed plans to meet with the FDA to address regulatory issues, as well as expand into European markets.

FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD

The REMS label update reduces the frequency of liver function monitoring and removes the embryo-fetal toxicity monitoring requirement.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy

If approved, the investigative therapy could provide a frontline treatment for patients with SAA who do not have matched sibling donors for cell transplantation.

FDA Accepts Priority Review Application of Omidubicel for Severe Aplastic Anemia

This episode highlights the groundbreaking approval of semaglutide for metabolic dysfunction-associated steatohepatitis, as well as GoodRx’s new Ozempic pricing.

Diabetes Dialogue: FDA Approves Semaglutide (Wegovy) for MASH

The FDA has approved Ionis Pharmaceuticals' donidalorsen to prevent HAE attacks in adults and children over 12 years.

FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks

With positive topline phase 2 results, parent company Crinetics Pharmaceuticals, Inc., has announced plans to begin phase 3 testing in the second half of 2025.