June 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,...
The FDA approved sacituzumab govitecan-hziy (Trodelvy) as monotherapy, and with pembrolizumab-based therapy, for select adults with previously untreated unresectable locally advanced or metastatic...
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...
On March 25, the FDA has approved relacorilant (Lifyorli), in combination with nab-paclitaxel for adults with platinum-resistant ovarian and related gynecologic cancers who have received prior systemic...