May 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, based on...
The FDA approved Enhertu for neoadjuvant treatment of adults with HER2-positive stage II or III breast cancer and adjuvant treatment of patients with residual invasive disease after neoadjuvant therapy.
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On May 1, the FDA approved vepdegestrant (Veppanu), a heterobifunctional protein degrader, for adults with estrogen receptor–positive, human epidermal growth factor receptor 2–negative, ESR1-mutated...
The US Food and Drug Administration has expanded the approval of Faslodex, a hormonal therapy for the treatment of breast cancer first approved in 2002.
The US Food and Drug Administration recently approved a new treatment option for patients with early stage HER2-overexpressed/amplified breast cancer. For recommended dosage and common adverse events, read...
The FDA converted Ibrance to regular FDA approval and approved a supplemental New Drug Application for the drug, broadening its range of antihormonal therapy.
