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 ...

FDA worked with GSK to update Wellcovorin labelling for safe, effective use in adult and paediatric CFD-FOLR1 patients.

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 ...

Not long after Novo Nordisk received an untitled letter from the FDA disputing certain elements of the first TV spot for its Wegovy pill, another of the Danish drugmaker’s GLP-1 ads is in the ...

Marketing Surveillance (PMS), often referred to as Phase IV clinical trials, is the systematic and ongoing monitoring of a drug's safety, efficacy, and real-world performance after it receives ...

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...

Poherdy is the first interchangeable biosimilar to Perjeta, approved for HER2-positive breast cancer, expanding access to targeted therapies. Biosimilars like Poherdy meet rigorous FDA standards, ...