July 17, 2026
Drug Approvals
Leqembi® (lecanemab-irmb) – Updated dosing, new strength
July 13, 2026 - The FDA announced the approval of a new starting dosage regimen for the subcutaneous (SC) formulation of Eisai and Biogen’s Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease.
Drug Approvals
Sarclisa Escena™ (isatuximab-irfc) – New formulation approval
July 9, 2026 - The FDA announced the approval of Sanofi’s Sarclisa Escena (isatuximab-irfc), a subcutaneous (SC) formulation of Sarclisa® (isatuximab-irfc).
Clinical Updates
Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab/berahyaluronidase alfa-pmph) plus Padcev® (enfortumab vedotin-ejfv) – Expanded indication
July 10, 2026 - The FDA announced the approval of Merck’s Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab/berahyaluronidase alfa-pmph), each in combination with Pfizer’s Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC).