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...
April 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 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 FDA has approved dextromethorphan-bupropion extended-release tablets for agitation associated with Alzheimer disease dementia, offering clinicians a non-antipsychotic treatment option supported by...
The FDA has approved a supplemental indication for lumateperone to reduce relapse risk in adults with schizophrenia based on phase 3 randomized withdrawal data.
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,...
