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Mar 06, 2026
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
Mar 06, 2026
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
Oct 01, 2025
The FDA approved Zycubo (copper histidinate) on January 13, 2026, as the first treatment for Menkes disease in pediatric patients, following resolution of manufacturing compliance concerns that led to an initial rejection in September 2025.
Jan 16, 2026
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
Feb 12, 2026
The FDA approved pembrolizumab (Keytruda) and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian carcinoma based on Phase 3 trial data showing improved survival outcomes.
