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., 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 ...
* Anticipates a six-month FDA review timeline with potential for approval and launch in Q4 of 2017 * Amag Pharmaceuticals - if makena auto-injector is approved, Amag will request orange book listing ...
In February 2018, the company received FDA approval for the label expansion of Feraheme and Makena. The FDA approved the label expansion of Feraheme (ferumoxytol injection) beyond the current CKD ...
Makena was the first FDA-approved treatment option for pregnant women who have had prior spontaneous preterm birth. AMAG Pharmaceuticals announced that the Food and Drug Administration (FDA) has ...
The Makena subcutaneous auto injector product has been well received by healthcare professionals and patients, and AMAG believes the value proposition of the product could meaningfully extend the life ...
AMAG announced Thursday that the FDA has approved it's Makena subcutaneous auto-injector drug-device combination product. Makena is a drug used to reduce the risk of preterm birth in at-risk women.
Amag Pharmaceuticals Inc., of Waltham, reported results from its pharmacokinetic study designed to demonstrate comparable bioavailability of the subcutaneous auto-injector product and the current ...
* AMAG Pharmaceuticals Inc says plan to submit a supplemental new drug application to FDA for Makena subcutaneous auto-injector in Q2 of 2017 Source text for Eikon: Further company coverage: ...
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 ...