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FDA beats EMA to most approved new drugs in 2024
The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies ...
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FDA protocol deviation guidance could go further
A protocol violation is a significant occurrence or event which may affect participant safety or the integrity of the research, or a consistent variation ... EMA guidance, but I have not seen FDA ...
pharmaphorum8y
FDA and EMA to work more closely on paediatric drug regulation
The FDA and EMA require all new drugs to have plans for paediatric development included in their file, unless companies can obtain waivers or deferrals. The plans can be worth big money to ...
pharmaphorum6d
After FDA snub, EMA backs FibroGen, Astellas' roxadustat
The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned ... after the EMA's CHMP scientific ...
Business Insider1mon
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, and the European Medicines Agency, EMA, has validated ...
Pharmabiz10d
US FDA & EMA grant orphan drug designation to Bioxodes’ haemorrhagic stroke therapeutic candidate, BIOX-101
The FDA and EMA grant ODD to diseases that are rare, and receive little research funding as a result. Only 13% of strokes are classified as ICH, yet these account for 40% of all stroke-related deaths, ...