August 10, 2026

FDA Approves Melanoma BRAF Companion Test

The assay is indicated to identify patients with advanced melanoma who have BRAF V600E or BRAF V600K variants and may benefit from FDA-approved targeted therapies.

MDSpire News

August 07, 2026

FDA Approves Viral Therapy Plus Nivolumab

Accelerated approval is based on objective response rate and duration of response in advanced melanoma, with postapproval trials required to confirm clinical benefit.

MDSpire News

August 06, 2026

FDA Approves mRNA Flu Vaccine

The FDA based its approval for adults aged 50 to 64 years on phase 3 trial results, while use in adults aged 65 years and older received accelerated approval.

MDSpire News