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 ...

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 ...

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 ...

Targeting GLP-1 receptors now has the FDA’s blessing as a way to treat the fatty liver disease called MASH with Novo Nordisk’s weekly injectable drug Wegovy becoming the second approved treatment for ...

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 ...

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 ...

Oct. 3 (UPI) --The Trump administration this week approved a second generic abortion pill despite opposition from Republicans and anti-abortionists. The Food and Drug Administration approved the ...