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 ...
BRUSSELS, Dec 2 (Reuters) - The European Union's drug regulator said on Wednesday that its longer approval process for COVID-19 vaccines was safer, after Britain granted an emergency authorisation to ...
Anavex Life Sciences faces a pivotal EU regulatory decision for its Alzheimer’s drug blarcamesine, with a binary outcome likely to move the stock. AVXL’s Phase 2B/3 trial met cognitive but not ...
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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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 ...
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