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...
The FDA approved expanded adjuvant therapy options for adults with renal cell carcinoma with a clear cell component who are at intermediate-high or high risk of recurrence after nephrectomy, with or without...
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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The FDA approved oral decitabine and cedazuridine (Inqovi) tablets with venetoclax for adults with newly diagnosed acute myeloid leukemia who are aged 75 years or older or have comorbidities that preclude...
The FDA approved Bizengri for adults with advanced, unresectable, or metastatic NRG1 fusion-positive cholangiocarcinoma after prior systemic therapy, providing a new targeted option for an ultra-rare and...
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...
The FDA has granted full approval for the use of brexucabtagene autoleucel in adults with relapsed or refractory mantle cell lymphoma, based on confirmatory ZUMA-2 data.
