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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...
WALTHAM, Mass., Oct. 24, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its third quarter 2019 financial results will be released on Friday, November 1, 2019 before the U.S. financial markets open. Management will host a conference call and webcast a...
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WALTHAM, Mass., Oct. 11, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced that the data from its two pivotal, double-blind placebo-controlled Phase 3 trials ( RECONNECT ) and its voluntary open-label one year extension studies were published in Obstetrics &...
WALTHAM, Mass., Oct. 08, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (“AMAG”) today announced that it has entered into a settlement agreement with Caligan Partners LP (“Caligan”). As part of this agreement, the Board of Directors has appoin...
Company Thesis The FDA’s AdCom meeting this October with regards to a clinical review of Makena’s updated efficacy and safety profiles is likely to result in a total withdrawal of the product from the market. On the other hand, Amag's ( AMAG ) recent Vyleesi launch for the tr...
AMAG’s Recent Public Letter Demonstrates Complete Disregard for Shareholders Current Board’s Poor Decisions, Strategic Missteps and Lax Oversight Have Destroyed $1.1 Billion in Shareholder Value over Past Seven Years Fresh Perspectives are Urgently Needed in B...
WALTHAM, Mass., Sept. 25, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) will participate in the Cantor Fitzgerald Global Healthcare Conference in New York on Thursday, October 3, 2019. Ted Myles, chief financial officer, will participate in a fireside chat at 10:40 a.m. ...
The FDA will hold an advisory committee meeting on Tuesday, October 29, to review and discuss the results from a failed Phase 3 clinical trial, PROLONG , evaluating AMAG Pharmaceuticals' ( AMAG -1.9% ) Makena (hydroxyprogesterone caproate injection) for preventing preterm births in women ...
Details Caligan Partners’ Reckless Business Ideas and Inexperienced Director Nominees Urges Shareholders to Sign and Return AMAG’s GREEN Consent Revocation Card WALTHAM, Mass., Sept. 23, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (“A...
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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...