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 ...
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 ...
May 13, 2025 2:17 PM ETCellectar Biosciences, Inc. (CLRB) StockAI-Generated Earnings Calls Insights ...
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 ...
Inflammation that develops in chronic obstructive pulmonary disorder stems from different causes. A new regulatory decision in Europe makes Sanofi and Regeneron Pharmaceuticals drug Dupixent the first ...
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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 ...
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 ...
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