FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and ...

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 ...

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 ...

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 ...

Accelerated approval can serve patients well—but only when surrogate endpoints are reliable and clearly predict outcomes that matter to patients.

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 ...

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.

Please provide your email address to receive an email when new articles are posted on . The FDA expanded linaclotide approval for IBS-C to include children aged 7 years and older. Linaclotide is now ...

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 ...

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 ...

Add Yahoo as a preferred source to see more of our stories on Google. Leucovorin.Photograph: Hannah Beier/Reuters (Photograph: Hannah Beier/Reuters) This week, the Trump administration announced that ...