Showing posts with label New Drug Application (NDA). Show all posts
Showing posts with label New Drug Application (NDA). Show all posts
Tuesday, October 11, 2022

BioLineRx Announces Submission of New Drug Application (NDA) to FDA for Motixafortide in Stem Cell Mobilization

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BioLineRx Ltd.  announced the  submission of  its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Motixafortid...
Monday, December 27, 2021

Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALS

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  Sodium phenylbutyrate                Taurursodiol       Amylyx Pharmaceuticals, Inc.  announced that, it has submitted a New Drug Appli...
Monday, May 1, 2017

Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets

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In continuation of my update on Lorcaserin Eisai Inc. and Arena Pharmaceuticals, Inc.   announced   the approval by  U.S. Food and Drug ...
Tuesday, January 10, 2017

FDA Issues Complete Response Letter for Apadaz New Drug Application

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KemPharm, Inc.  a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs,  annou...
Thursday, May 2, 2013

FDA Approves Tris Pharma's New Drug Application for Karbinal ER

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In continuation of my update on Karbinal ( carbinoxamine maleate )... FDA,  has approved its New Drug Application (NDA) for Karbinal ...
Monday, December 17, 2012

Pfizer, Ligand announce FDA acceptance of bazedoxifene/conjugated estrogens NDA

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Pfizer Inc.   and Ligand Pharmaceuticals Incorporated recently,  announced that the United States Food and Drug Administration (FDA) ...