fda approval

New analysis of Biogen’s aducanumab shows reduction in clinical decline in Alzheimer’s disease.

Kyowa Hakko Kirin's Parkinson's therapy, Nourianz (istradefylline), gains FDA approval as an add-on to levodopa/carbidopa.

Vyndaqel (tafamidis) is now approved in the U.S. after study showed increased survivorship rate and reduced hospital time due to heart related problems.

The new site-agnostic cancer medicine, Vitrakvi (larotrectinib), gets accelerated approval from the U.S. Food and Drug Administration (FDA).

Phase III trial shows that Copiktra (duvelisib) may be an option for patients with relapsed or refractory chronic lymphocytic leukaemia and small lymphocytic lymphoma.

A new biosimilar, Truxima (rituximab), shows comparable results to the reference medicine, Rituxan (rituximab), and takes FDA one step further toward expanding patient access to medicines.