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

ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...

The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and political priority setting.

The Food and Drug Administration (FDA) on Tuesday granted expanded approval to Wellcovorin for the ultra-rare disease cerebral folate deficiency (CFD) in both children and adults, the same ...

The patented technology could help reduce repeat procedures in an estimated 300,000 breast cancer surgeries annually.

The Tecnis PureSee IOL is the first FDA-approved extended depth of focus IOL maintaining contrast sensitivity comparable to ...

The FDA declined to endorse leucovorin as a treatment for autism, but approved the drug to treat cerebral folate deficiency, ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

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 ...

Unlike treatments that focus on removing plaques that have already formed, levetiracetam works differently. It blocks the ...