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 ...
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 ...
The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide ...
The US FDA has approved two companies’ COVID vaccines that target the latest variant of the virus for adults aged at least 65 years and individuals at high risk for severe outcomes, according to ...
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 ...
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 ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results