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Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson's Disease Based on Existing Pivotal Clinical Trial Data
SAN DIEGO, Feb. 14, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, today announced that the U.S. Food and Drug Administration (FDA) has provided... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 14, 2018 Category: Pharmaceuticals Source Type: clinical trials

Verastem Announces Regulatory Strategy for Duvelisib New Drug Application Following Guidance from FDA
BOSTON--(BUSINESS WIRE)--Oct. 31, 2017-- Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of patients with cancer, today announced that a meeting was held with the U.S. Food and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 31, 2017 Category: Pharmaceuticals Source Type: clinical trials

VBI Vaccines Announces FDA Acceptance of Investigational New Drug Application for VBI-1901 to Treat Glioblastoma Multiforme
(Source: Clinical Trials And Noteworthy Treatments For Brain Tumors)
Source: Clinical Trials And Noteworthy Treatments For Brain Tumors - August 16, 2017 Category: Cancer & Oncology Source Type: clinical trials

Shire submits investigational New Drug Application to FDA for Gene Therapy candidate SHP654 for treatment of Hemophilia A
Lexington, Mass. – July 6, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving people with rare diseases, today announced the submission of an investigational new drug (IND) application to the U.S.... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 6, 2017 Category: Pharmaceuticals Source Type: clinical trials

Adamas Announces Publication of ADS-5102 Phase 3 EASE LID Clinical Trial in JAMA Neurology
EMERYVILLE, Calif., June 12, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that results of its Phase 3 EASE LID clinical trial of ADS-5102 were published online in JAMA Neurology. A New Drug Application... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 12, 2017 Category: Pharmaceuticals Source Type: clinical trials

Protalix Announces FDA Investigational New Drug Clearance to Commence Once-Monthly Dosing Study of Pegunigalsidase Alfa (PRX-102) for the Treatment of Fabry Disease
CARMIEL, Israel, May 09, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that the U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug application (IND) for a clinical trial... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 9, 2017 Category: Pharmaceuticals Source Type: clinical trials