Showing posts with label New Drug Application. Show all posts
Showing posts with label New Drug Application. Show all posts
Friday, August 16, 2024

Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration

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Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (NDA)...
Thursday, August 15, 2024

Zealand Pharma Submits New Drug Application to the US FDA for Glepaglutide in Short Bowel Syndrome

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Zealand Pharma A/S  announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for glepaglutide, ...
Wednesday, August 14, 2024

Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea

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Journey Medical Corporation,  announced that the Company has submitted,  a New Drug Application (“NDA”) to the FDA seeking approval for DFD-...
Friday, August 9, 2024

Amneal Announces Complete Response Resubmission for IPX203 New Drug Application

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Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has provided a Complete Response resubmissio...
Thursday, August 8, 2024

Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adults

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Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced the...
Wednesday, August 7, 2024

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD

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Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental healthcare, an...
Monday, August 5, 2024

Liquidia Corporation Provides Update on New Drug Application for Yutrepia (treprostinil) inhalation powder

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Liquidia Corporation (the Company) (NASDAQ: LQDA) announced  the U.S. Food and Drug Administration (FDA) providing  an update on its review ...
Monday, October 10, 2022

Cidara Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

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Cidara Therapeutics, Inc.  , a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patien...
Monday, September 12, 2022

Acadia Pharmaceuticals Announces Trofinetide New Drug Application for the Treatment of Rett Syndrome has been Accepted for Filing and Review by U.S. FDA

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About Rett Syndrome Rett syndrome is a rare genetic neurodevelopmental disorder that occurs primarily in females following a near normal dev...
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...
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...
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...
Wednesday, April 29, 2020

FDA Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar Disorder

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 Alkermes plc (Nasdaq: ALKS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug...