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 ...
Sevabertinib received FDA accelerated approval for nonsquamous NSCLC with HER2 TKD mutations, based on the SOHO-01 trial results. Patients naïve to HER2-targeted therapies showed a 71% ORR and a ...
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 ...
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.
Jaypirca received traditional approval for relapsed/refractory CLL/SLL, showing improved progression-free survival compared to investigator's choice therapy. Breyanzi was approved for ...
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 ...
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