Thursday, January 27, 2022

Spectrum Pharmaceuticals Submits New Drug Application for Poziotinib

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Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, announced the submission of  its New...
Wednesday, January 26, 2022

FDA Approves Leqvio (inclisiran), First-in-Class siRNA to Reduce Low-Density Lipoprotein Cholesterol (LDL-C)

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Novartis  announced the US Food and Drug Administration (FDA) approval of Leqvio ®  (inclisiran), the first and only small interfering RNA (...
Monday, January 24, 2022

FDA Approves Apretude

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  ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Lim...
Friday, January 7, 2022

New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis

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    Spero Therapeutics, Inc. announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seeki...
Thursday, January 6, 2022

Spectrum Pharmaceuticals Submits New Drug Application for Poziotinib for metastatic NSCLC with HER2 exon 20 insertion mutations.

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                     Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies,  announced tha...
Wednesday, January 5, 2022

Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome

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  Stealth BioTherapeutics Corp, announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Adminstration (FDA) for e...
Tuesday, January 4, 2022

Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 (meloxicam-rizatriptan) for the Acute Treatment of Migraine

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  In continuation of my update on meloxicam,  Axsome Therapeutics, Inc.   that the U.S. Food and Drug Administration (FDA) has accepted for ...
Monday, January 3, 2022

Marinus Announces FDA Acceptance for New Drug Application for Ganaxolone in CDKL5 Deficiency Disorder

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         Marinus Pharmaceuticals, Inc.  announced  the U.S. FDA acceptance for filing the company’s New Drug Application (NDA) for the use o...
Friday, December 31, 2021

Arcutis Submits Topical Roflumilast Cream New Drug Application for the Treatment of Adults and Adolescents with Plaque Psoriasis

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Arcutis Biotherapeutics, Inc. In continuation of my update on  roflumilast has submitted a new drug application (NDA) to the U.S. Food and ...
Thursday, December 30, 2021

Spero Therapeutics Submits New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis

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    Spero Therapeutics, Inc. announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seekin...
Tuesday, December 28, 2021

Incyte Announces Acceptance of NDA for Parsaclisib for Refractory Non-Hodgkin Lymphomas

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      Incyte (Nasdaq:INCY)  announced,  that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for par...
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...
Thursday, December 23, 2021

FDA Grants Tentative Approval for Liquidia’s Yutrepia (treprostinil) Inhalation Powder

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 In continuation of my update on treprostinil   Liquidia Corporation  announced that, the U.S. Food and Drug Administration (FDA) has grant...