Showing posts with label FDA Acceptance. Show all posts
Showing posts with label FDA Acceptance. Show all posts
Thursday, April 2, 2026

FDA Accepts Shionogi’s Ensitrelvir NDA for Review as the First Oral Therapy for the Prevention of COVID-19 Following Exposure

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Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the U.S...
Wednesday, April 1, 2026

Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation

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Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercializ...
Monday, August 12, 2024

Bridgebio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

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BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseas...
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, 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, 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...
Monday, December 20, 2021

Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix

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Obseva SA   announced   the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine...
Thursday, January 30, 2020

Blueprint Medicines Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

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Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases ...
Wednesday, January 29, 2020

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105

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In continuation of my update on    lamotrigine Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused ...