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 ...
(Reuters) - AMAG Pharmaceuticals Inc said the U.S. Food and Drug Administration rejected a single dose of its hormone injection used to reduce the risk of premature birth, the agency's second rebuff ...
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 ...
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 ...
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 ...
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