46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

The US FDA approved 46 new drugs in 2025, despite a tumultuous year at the regulatory agency.

Optum notable drugs nearing FDA approval include Anaphylm, Sotyktu, and insulin icodec with decisions expected early 2026.

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...

Below is a review of novel drug and biological products approved by the Food and Drug Administration (FDA) in 2025. The list includes several groundbreaking therapies that are expected to change the ...

The FDA is expected to decide on treatments for allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia.

After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after ...

The Food and Drug Administration has approved the first GLP-1 pill for weight loss, its manufacturer Novo Nordisk announced Monday, a milestone in the growth of the revolutionary drugs. The drug, a ...

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.