#FDA approval

The antibody-drug conjugate Tivdak led to remission in 24% of cervical cancer patients.

Exkivity is approved for adults with advanced non-small-cell lung cancer with specific EGFR mutations.

The IDH1 inhibitor is the third medication approved this year for hard-to-treat bile duct cancer.

An advisory panel reviewed follow-up data on checkpoint inhibitors, voting to maintain four approvals and rescind two.

The immunotherapy is now approved to treat tumors with a specific genetic mutation anywhere in the body.

Full approval could encourage more people to get vaccinated and raises the prospect of off-label use.

The booster is recommended for organ transplant recipients, people receiving cancer treatment and people with advanced or untreated HIV.

Targeted therapy and immunotherapy combination doubles response rate for people with advanced renal cell carcinoma.

This is the first immunotherapy approved for previously untreated triple-negative breast cancer that is likely to relapse.

New recombinant drug may be an option for patients with hypersensitivity to standard asparaginase chemotherapy.

Alzheimer’s advocates laud the approval of Aduhelm, but experts raise questions about its effectiveness and cost.

Here are the latest new cancer drugs approved by the Food and Drug Administration.

The Food and Drug Administration created its accelerated approval program to enable more rapid approval of therapies for serious conditions.

The agent is approved for use in men suspected of having either metastatic or recurrent forms of prostate cancer.

Lumakras led to tumor shrinkage in 36% of NSCLC patients with KRAS G12C mutations.