FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.

Inluriyo, an oral estrogen receptor antagonist, significantly reduced disease progression risk in ESR1-mutated metastatic breast cancer, as shown in the EMBER-3 trial. Keytruda Qlex, a subcutaneous ...

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

In a scathing rebuke (PDF) to AstraZeneca, the FDA cited “critical data quality issues that affect key analyses, including the primary endpoint” within a dataset for Saphnelo (anifrolumab) for the ...

The FDA approved Dupixent as the first treatment for allergic fungal rhinosinusitis in adults and children over six years old ...

Not long after Novo Nordisk received an untitled letter from the FDA disputing certain elements of the first TV spot for its ...

The Food and Drug Administration (FDA) has approved some medications for weight loss. If a medication is FDA-approved, it means the FDA has determined it’s safe and effective for a certain use.