pharmaphorum3d
When measuring European regulatory approval, the timestamp matters
specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Last year we wrote a three-part series, "Life in the Fast ...
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European Medicines Agency Delays Approval Decision For Biogen-Eisai Partnered Alzheimer's Drug Lecanemab
This delay, attributed to procedural issues at the European Medicines Agency (EMA), has implications ... Reuters noted that an approval is expected in the second half of 2024, versus Eisai ...
WION4y
EU's medicines agency responsible for vaccine approval suffers cyber attack
As Europe prepares to roll out the coronavirus vaccine, the European Medicines Agency(EMA) said today that it was targeted in a cyber attack. The EMA is responsible for approving various medicines ...
Acadia Pharma Submits MAA To EU Agency For Approval Of Trofinetide In Rett Syndrome
(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) Tuesday, announced the submission of a Marketing Authorization Application or MAA to the European Medicines Agency or EMA for its Trofinetide, targeting ...
Business Wire1mon
CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union
ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ... s approval for subcutaneous use ...
Nasdaq15d
Acadia Pharma Submits MAA To EU Agency For Approval Of Trofinetide In Rett Syndrome
(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) Tuesday, announced the submission of a Marketing Authorization Application or MAA to the European Medicines Agency ... is already approved in the ...