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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 ...
pharmaphorum3d
EMA’s strategy for speeding up drug approvals in the EU
With the average R&D cost for drug development being $2.3 ... The conclusion of the agency’s review sees the EMA plan to tackle delays in medicine approval by enhancing both submission ...
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Playing The Odds Of Anavex Alzheimer's Drug Approval
The EMA has accepted Anavex's Alzheimer's drug Blarcamesine for evaluation, with a decision expected by December 2025. Blarcamesine shows a 92% likelihood of approval by the EMA, yet investors ...
Medscape11d
EMA to Review New Safety Data on Alzheimer’s Drug Leqembi
The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
Pharmaceutical Technology6d
Italian charity seeks EMA approval for rescued gene therapy
Telethon Foundation is seeking approval for a gene therapy to treat the rare disease Wiskott-Aldrich syndrome.
FiercePharma11d
Merck vaccine, Daiichi ADC win approval recommendations in busy week at EU's drug regulator
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...