Showing posts with label Acceptance. Show all posts
Showing posts with label Acceptance. Show all posts
Monday, July 20, 2026

Egetis Announces FDA Acceptance and Priority Review of NDA for Emcitate (tiratricol) for MCT8 Deficiency

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Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (NASDAQ Stockholm: EGTX), today announced that the U.S. Food and Drug Administrati...
Monday, June 29, 2026

Elevar Therapeutics Announces FDA Acceptance for Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma Treatment

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Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevat...
Friday, June 5, 2026

Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL

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Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), t...
Tuesday, February 4, 2020

Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma

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Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U...
Friday, May 3, 2019

Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine

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    Allergan plc (NYSE: AGN)  announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Applicati...
Friday, March 29, 2019

Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant

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     Harmony Biosciences, LLC (Harmony), announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New ...