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Latest Committee for Medicinal Products for Human Use Stories

2014-07-30 08:32:50

SAN DIEGO, July 30, 2014 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced it has received the Day 180 List of Outstanding Issues (LOI) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the NB32 Marketing Authorization Application (MAA). NB32 (naltrexone sustained release (SR) / bupropion SR) is an investigational drug candidate being evaluated for weight loss. The key questions of the earlier Day 120 time point...

2011-06-24 05:10:00

EXTON, Pa., June 24, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a Pediatric Use Marketing Authorization (PUMA) for Buccolam® (midazolam, oromucosal solution), for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less...

2011-03-18 08:35:00

EXTON, Pa., March 18, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion at its plenary meeting in March 2011 recommending approval of a Centralized Marketing Authorization for Cinryze® (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema (HAE) for routine prevention, pre-procedure prevention...


Word of the Day
bodacious
  • Remarkable; prodigious.
  • Audacious; gutsy.
  • Completely; extremely.
  • Audaciously; boldly.
  • Impressively great in size; enormous; extraordinary.
This word is probably from the dialectal 'boldacious,' a blend of 'bold' and 'audacious.'
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