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...
March 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 November 10, the U.S. Department of Health and Human Services announced that the FDA is initiating the removal of certain black box warnings from hormone replacement therapy products for menopause,...
Secretary Robert F. Kennedy Jr. announced that the CDC will no longer recommend the COVID-19 booster vaccine for healthy children and pregnant people. The announcement comes despite previous CDC...
In June, following a placebo-controlled trial, the FDA approved pembrolizumab with chemotherapy to treat patients with primary advanced or recurrent endometrial carcinoma.
