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 ...

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

has accepted the company’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen for spinal ...

The FDA, meanwhile, is responsible for regulating — and slapping a nutrition facts label — on all processed foods created and sold in the U.S. Though many Americans may think the USDA is the ...

The green light was expected after the EMA's CHMP scientific committee in June, which issued a positive opinion on Evrenzo based on phase 3 trial results which showed the drug helped people with ...

and the FDA and EMA believe this approach could become a template for other rare disease drugs. The move is designed not only to make orphan drug R&D faster and cheaper for pharma, but also ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

M.D., for U.S. Food and Drug Administration (FDA) commissioner, and Brooke Rollins for secretary of agriculture. If confirmed, Kennedy, Makary, and Rollins will inherit several ongoing food ...

Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started reviewing a higher dose regimen of its spinal muscular atrophy (SMA) treatment ...

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 ...