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 ...

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 ...

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 ...

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...

Amgen (AMGN) and AstraZeneca (AZN) are approaching a potential catalyst event on October 19, when the FDA will rule on Tezspire for treating chronic rhinosinusitis with nasal polyps (CRSwNP). If ...

Please provide your email address to receive an email when new articles are posted on . The FDA based nerandomilast’s approval on results from two trials, one of which was the FIBRONEER-IPF trial.

Findings showed treatment with rucaparib significantly improved rPFS compared with physician’s choice of treatment. The Food and Drug Administration (FDA) has granted traditional approval to Rubraca ® ...

The FDA has approved the supplemental new drug application for topical roflumilast cream 0.05% for treating mild-to-moderate atopic dermatitis in children aged 2-5 years, the manufacturer announced in ...