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 ...

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 ...

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 ...

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 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 ...

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 ...