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Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access P drugs.com
September 23, 2020
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases today announced that it has submitted the first portion of its rolling New Drug ...
Apellis to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria americanpharmaceuticalreview
May 27, 2020
Apellis Pharmaceuticals announced plans to submit a New Drug Application (NDA) for pegcetacoplan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the second half of 2020.
Heron Receives FDA Extension of NDA Review Period for Postoperative Pain Treatment americanpharmaceuticalreview
March 09, 2020
Heron Therapeutics announced the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for HTX-011 by up to three months.
Alnylam initiates rolling submission of NDA for Lumasiran in primary Hyperoxaluria Type 1 pharmaceutical-business-review
January 15, 2020
Alnylam Pharmaceuticals has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperox
Blueprint Announces Top-line Data for Pralsetinib, Initiates Rolling NDA Submission americanpharmaceuticalreview
January 14, 2020
Blueprint Medicines announced independent centrally reviewed top-line data for pralsetinib in patients with RET fusion-positive non-small cell lung cancer (NSCLC).
Sunovion Announces FDA Filing Acceptance of Resubmitted NDA for Apomorphine Sublingual Film americanpharmaceuticalreview
December 24, 2019
Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for apomorphine sublingual film (APL-130277) ...
Nabriva Therapeutics Resubmits NDA for Intravenous CONTEPO americanpharmaceuticalreview
December 23, 2019
Nabriva Therapeutics has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CONTEPO™ (fosfomycin) for ...
Avenue Therapeutics Announces NDA Submission for IV Tramadol americanpharmaceuticalreview
December 17, 2019
Avenue Therapeutics has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV tramadol for the management of moderate to ...
Gilead Sciences submits NDA to treat RA in Japan biospectrumasia
October 10, 2019
Gilead Sciences, Inc. has announced the New Drug Application (NDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis (RA) has been submitted to the Japanese Ministry of Health, Labor a
Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial drugs
August 15, 2019
Kala Pharmaceuticals, Inc. announced that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s new drug application (NDA) for...

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