July 11, 2026

The FDA has approved Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim), for adults and children. Developed by Accord BioPharma, it is the eighth pegfilgrastim biosimilar approved in the United States. The drug is supplied as a single-dose prefilled syringe and helps reduce the risk of infection by increasing white blood cell production in patients receiving […]

The FDA has expanded the approval of pembrolizumab (Keytruda) or the subcutaneous formulation Keytruda Qlex, in combination with enfortumab vedotin (Padcev), for adults with muscle-invasive bladder cancer (MIBC). The regimen can now be used before surgery (neoadjuvant therapy) and after bladder removal surgery (adjuvant therapy) for all patients who are eligible for surgery, regardless of

The FDA has approved a subcutaneous (under-the-skin) formulation of isatuximab-irfc (Sarclisa Escena) for all indications previously covered by the intravenous (IV) version in multiple myeloma. The treatment can be administered using the wearable CirCLIQ on-body delivery system or a manual syringe, making it the first FDA-approved cancer therapy delivered through an on-body injector. The approval