WALTHAM, Mass., March 08, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today topline results from PROLONG (Progestin's Role in Optimizing Neonatal Gestation), a ...
WALTHAM, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is ...
PRINCETON, N.J., Jan. 2, 2019 /PRNewswire/ -- Slayback Pharma LLC announced today that the U.S. Food and Drug Administration ("FDA") granted approval of its abbreviated new drug application ("ANDA") ...
Credit: FDA. The product was granted approval through the accelerated approval pathway in 2011. Following a 3 day meeting, the Food and Drug Administration’s (FDA) Obstetrics, Reproductive, and ...
Makena received accelerated approval in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The Food and Drug ...
Already under pressure from its shareholders, AMAG faced a big decision from an FDA advisory committee on the future of its troubled premature-birth med Makena. Now, with the committee voting against ...
A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to ...
An independent panel of advisers to the Food and Drug Administration recommended last week that a medication to prevent preterm birth be taken off the market because, the advisers decided, the ...
The 9-7 vote, which took place at a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee on Tuesday, came in response to evidence suggesting that the drug was not effective. The ...
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