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Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder
DUBLIN, July 15, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today provided an update on its regulatory strategy for ALKS 3831 (olanzapine/samidorphan), the company ' s investigational, novel, once-daily, oral atypical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 15, 2019 Category: Pharmaceuticals Source Type: clinical trials

Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 1, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration(FDA), the company provided an... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 1, 2019 Category: Pharmaceuticals Source Type: clinical trials

Albireo Announces FDA Clearance of IND to Commence Phase 2 Trial of Elobixibat for the Treatment of NAFLD/NASH
BOSTON, April 11, 2019 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that its Investigational New Drug application (IND) has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 11, 2019 Category: Pharmaceuticals Source Type: clinical trials

Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Tokyo and Basking Ridge, NJ– (April 4, 2019)– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 9, 2019 Category: Pharmaceuticals Source Type: clinical trials

Novo Nordisk Files for US FDA Approval of Oral Semaglutide for Blood Sugar Control and Cardiovascular Risk Reduction in Adults with Type 2 Diabetes
PLAINSBORO, N.J., March 20, 2019 /PRNewswire/ -- Novo Nordisk today announced the submission of two New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for oral semaglutide, the first once-daily glucagon-like peptide-1 (GLP-1)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 26, 2019 Category: Pharmaceuticals Source Type: clinical trials

VLP Therapeutics Receives FDA Clearance of Investigational New Drug Application and Initiates First Clinical Trial of VLPM01 Malaria Vaccine
Gaithersburg, MD– February 4, 2019 -- VLP Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a clinical trial of the Company’s VLPM01 malaria... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 4, 2019 Category: Pharmaceuticals Source Type: clinical trials

Kiniksa Announces Active U.S. Investigational New Drug Application for Mavrilimumab
HAMILTON, Bermuda, Jan. 03, 2019 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of five product candidates across various stages of development, today announced... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 3, 2019 Category: Pharmaceuticals Source Type: clinical trials

BeyondSpring Announces Positive Pre-NDA Meeting with the U.S. FDA for its Lead Asset, Plinabulin
NEW YORK, Dec. 27, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it had a positive pre-New Drug Application (NDA) meeting... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 27, 2018 Category: Pharmaceuticals Source Type: clinical trials

GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA)
SOUTH SAN FRANCISCO, Calif., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (Nasdaq: GBT) today announced that the U.S. Food and Drug Administration (FDA) has informed GBT through discussions and written correspondence that... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 3, 2018 Category: Pharmaceuticals Source Type: clinical trials

Ultragenyx Announces Intent to Submit New Drug Application to U.S. FDA for UX007 for the Treatment of Long-chain Fatty Acid Oxidation Disorders in Mid-2019
NOVATO, Calif., Nov. 14, 2018 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, today announced that it has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 14, 2018 Category: Pharmaceuticals Source Type: clinical trials

Clementia Announces Plan to Submit a New Drug Application for Palovarotene for the Treatment of FOP Based on Positive Phase 2 Results
MONTREAL, Oct. 23, 2018 (GLOBE NEWSWIRE) -- Clementia Pharmaceuticals Inc. (Nasdaq: CMTA), a clinical-stage biopharmaceutical company innovating treatments for people with ultra-rare bone disorders and other diseases, today announced that it plans... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 23, 2018 Category: Pharmaceuticals Source Type: clinical trials

Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 15, 2018-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company plans to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 15, 2018 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Priority Review to Genentech ’s Baloxavir Marboxil for the Treatment of Influenza
South San Francisco, CA -- June 25, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 25, 2018 Category: Pharmaceuticals Source Type: clinical trials

MediciNova Announces Opening of Investigational New Drug Application for MN-166 (ibudilast) in Glioblastoma
LA JOLLA, Calif., May 09, 2018 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 9, 2018 Category: Pharmaceuticals Source Type: clinical trials

Celgene Provides Regulatory Update on Ozanimod for the Treatment of Relapsing Multiple Sclerosis
SUMMIT, N.J.--(BUSINESS WIRE) February 27, 2018 -- Celgene Corporation (NASDAQ:CELG) today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 27, 2018 Category: Pharmaceuticals Source Type: clinical trials