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") ...
WALTHAM, Mass., June 26, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug ...
BAUDETTE, Minn., June 28, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the commercial launch of Hydroxyprogesterone Caproate Injection ("HPC") USP 250mg/mL in ...
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 ...
Please provide your email address to receive an email when new articles are posted on . Covis Pharma will voluntarily withdraw its preterm birth prevention drug Makena from the market. An FDA advisory ...
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 ...
Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA ...
Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA ...
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