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Shares of AMAG Pharmaceuticals (NASDAQ: AMAG) , a commercial-stage pharmaceutical company , fell as much as 30% in early-morning trading on Wednesday. Shares are down about 28% as of 11:00 a.m. EDT. The double-digit decline is traceable to an FDA committee vote that recommended that AMAG's b...
WALTHAM, Mass., Oct. 29, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the U.S. Food and Drug Administration’s (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG (Progestin’...
The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 16-0 that AMAG Pharmaceuticals' ( AMAG ) confirmatory study, Trial 003, failed to demonstrate Makena's effectiveness in reducing the risk of preterm births in women with histories of singleton spontaneous preterm birth....
WALTHAM, Mass., Oct. 29, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that NASDAQ has halted trading of the company’s common stock. The U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) is m...
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Gainers: Xunlei (NASDAQ: XNET ) +61% . Anika Therapeutics (NASDAQ: ANIK ) +36% . Reebonz Holding (NASDAQ: RBZ ) +25% . DMC Global (NASDAQ: BOOM ) +19% . AMAG Pharmaceuticals (NASDAQ: AMAG ) +16% . BJ's Restaurants (NASDAQ: BJRI ) +15% . Vipshop Holdings (NYSE: VIPS ) +15% . ResMed ...
WALTHAM, Mass., Oct. 25, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the results of PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) were published online in the American Journal of Perinatology . PROLONG was a randomized...
AMAG Pharmaceuticals ( AMAG +14.5% ) is up in early trade after the FDA posted the meeting materials for next Tuesday's meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee to review and discuss its supplemental marketing application seeking full approval of Makena (hydr...
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WALTHAM, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. has submitted its response to the FDA’s Notice of Opportunity for a Hearing (“NOOH”) regarding the Agency’s proposal to withdraw approval for Makena—also referred to as 17-OHP...
MGIC Investment & Halozyme Therapeutics Set to Join S&P MidCap 400; First Bancorp, The Geo Group & Mednax to Join S&P SmallCap 600 MGIC Investment & Halozyme Therapeutics Set to Join S&P MidCap 400; First Bancorp, The Geo Group & Mednax to Join S&...
WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena ® , the only F...