Friday, December 31, 2021

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

›
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

›
    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

›
      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

›
  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

›
 In continuation of my update on treprostinil   Liquidia Corporation  announced that, the U.S. Food and Drug Administration (FDA) has grant...
Wednesday, December 22, 2021

Submission of HTX-019 (aprepitant) NDA for the Prevention of Postoperative Nausea and Vomiting to FDA

›
        Heron Therapeutics, Inc.  announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) ...
Monday, December 20, 2021

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

›
Obseva SA   announced   the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine...