For the First Time, the FDA Takes Back a Breakthrough Therapy Designation
Insights - Merck (MRK) revealed on Wednesday that the U.S. FDA has rescinded a Breakthrough Therapy Designation for its investigational Hepatitis C treatment.
Read nowThe early innings of the obesity landscape is starting to take shape, and it seems to be forming similar patterns...
Read NowModular Medical (MODD) announced the 510(k) submission of their MODD1 insulin pump to the FDA last week. On average, the FDA takes approximately...
PremiumInsights - Merck (MRK) revealed on Wednesday that the U.S. FDA has rescinded a Breakthrough Therapy Designation for its investigational Hepatitis C treatment.
Read nowResearch - We see uniQure (QURE) as a dark horse in gene therapy, in-part because of numerous catalysts in 2015 that will put fresh eyes on this European company.
Read nowInsights - Spark Therapeutics (ONCE) lists publicly today, joining companies like bluebird bio (BLUE) and Avalanche (AAVL) as yet another emerging gene therapy player.
Read nowInsights - Intercept Pharmaceuticals (ICPT) added over $1 billion to its value in late trading when its lead drug received a Breakthrough Therapy Designation
Read nowResearch - Conatus (CNAT) was punished 2 weeks ago with the release of results from 3 phase I/II studies. Thankfully, we suggested taking profit beforehand at +60%.
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