The reform grants eight years of regulatory data and market protection, with extensions for drugs addressing unmet needs. EMA's procedures will be streamlined, reducing assessment times and ...
EMA and FDA define ten principles for AI use in medicines – in response to growing pressure from the industry.
STOCKHOLM, April 23, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that its lead product candidate Nefecon, a novel oral ...
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(RTTNews) - Annexon, Inc. (ANNX) announced the European Medicines Agency granted orphan drug designation to ANX005 for the treatment of Guillain-Barré Syndrome. Advantages of the orphan drug ...
AB Science S.A. (the "Company" - Euronext - FR0010557264 - AB) today provides an update on the schedule for the evaluation by the Committee for Medicinal Products for Human Use (CHMP) of the European ...
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