Discover the EMA's role in promoting safe medicine access in the EU. Learn about its responsibilities in drug evaluation, supervision, and pharmacovigilance.
Novo Nordisk has received the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approval for the Rybelsus (oral semaglutide) label update. The label will now ...
Just ahead of the EMA setting out its latest thinking on regulation in the new era of artificial intelligence (AI), the industry has put forward its position on how to ensure AI rules enable, rather ...
X4 Pharmaceuticals announced the validation of its Marketing Authorization Application (MAA) for mavorixafor, a treatment for WHIM syndrome, by the European Medicines Agency (EMA). This rare primary ...
On April 15, two years after Eisai requested a marketing license for lecanemab in Europe, the European Commission has greenlit its use. The biologic’s long path included an initial rejection from the ...
A novel non-antibiotic approach to diarrhea treatment is important because there are no FDA-approved drugs to treat general diarrhea in dogs, the second most common reason for visits to veterinary ...
Hosted on MSN
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 ...
BARCELONA, Spain — The challenges of accessing oncology drugs are not limited to low- and middle-income countries but also affect high-income nations. This was highlighted here by experts at the ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback