Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta
If Approved, Bulevirtide Will Be the First Treatment Option for Adult Patients in the U. S. With Chronic Hepatitis Delta Virus Infection With Compensated Liver Disease
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 19, 2021-- Gilead Sciences, Inc.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 19, 2021 Category: Drugs & Pharmacology Source Type: news
Heron Therapeutics Announces Submission of HTX-019 NDA for the Prevention of Postoperative Nausea and Vomiting to FDA
SAN DIEGO, Nov. 18, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 18, 2021 Category: Drugs & Pharmacology Source Type: news
FDA Grants Tentative Approval for Liquidia ’s Yutrepia (treprostinil) Inhalation Powder
First dry-powder formulation of treprostinil to meet criteria required for FDA approval
Final FDA approval may occur in October 2022 or earlier upon resolution of on-going litigation
MORRISVILLE, N.C., Nov. 08, 2021 (GLOBE NEWSWIRE) --... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 8, 2021 Category: Drugs & Pharmacology Source Type: news
Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALS
CAMBRIDGE, Mass.–(BUSINESS WIRE)– November 2, 2021 -- Amylyx Pharmaceuticals, Inc. today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate (PB) and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2021 Category: Drugs & Pharmacology Source Type: news
Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas
Priority Review granted to NDA for relapsed or refractory marginal zone lymphoma and mantle cell lymphoma
Standard Review for NDA for relapsed or refractory follicular lymphoma
WILMINGTON, Del.--(BUSINESS WIRE) November 1, 2021 -- Incyte... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 1, 2021 Category: Drugs & Pharmacology Source Type: news
