Timeline Snapshot
timeline snapshot
Timeline Snapshot
06/29/2026
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,...
06/29/2026
FDA Approval
FDA Approval
06/26/2026
Anthony Calabro, MA
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...
06/26/2026
FDA Alert
FDA Alert
05/22/2026
Anthony Calabro, MA
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...
05/22/2026
FDA Alert
FDA Alert
05/21/2026
Anthony Calabro, MA
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. ...
05/21/2026
FDA Approval
FDA Approval
05/04/2026
Anthony Calabro, MA
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...
05/04/2026
FDA Alert
FDA Alert
04/23/2026
Anthony Calabro, MA
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...
04/23/2026