research reports and media, page-1845

There has been some interesting happenings around the world about declining FDA approved drugs in other countries. I'm just adding this to the ever growing information regarding FDA we have gathered. As a reminder......Some countries will actually make decisions on their own about drugs.

July 23, 2021 09:49 AM EDT Pharma
EMA rejects FDA-approved Parkinson's drug, signs off on Moderna vaccine use in adolescents ahead of FDA
https://endpts.com/ema-rejects-fda-approved-parkinsons-drug-signs-off-on-moderna-vaccine-use-in-adolescents-ahead-of-fda/

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.
EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”