Sentences with phrase «investigational new drug application»

February 6, 2017 — Aura Biosciences Receives FDA Clearance of Investigational New Drug Application for Light - activated AU - 011 for the Treatment of Ocular Melanoma

Aura Biosciences Receives FDA Clearance of Investigational New Drug Application for Light - activated AU - 011 for the Treatment of Ocular Melanoma

Since the mid-1990s, FDA has deemed that organisms used in challenge studies are experimental medicines, and the agency has required researchers to submit Investigational New Drug applications before conducting trials.

Because of the legislation, a FDA spokesperson noted in an email, «the agency will not receive or review INDs [Investigational New Drug applications] for human subject research utilizing genetic modification of embryos for the prevention of transmission of mitochondrial disease in FY 2016 and human subject research using these technologies can not be conducted in compliance with the Federal Food, Drug, and Cosmetic Act and FDA's implementing regulations.»

He has initiated multiple trials under investigational new drug applications using infused T cells and natural killer (NK) cells.

ViaCyte, Inc. announced in July 2014 that it had filed its first Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence.

The company submitted a 22,500 - page Investigational New Drug application to the FDA for an embryonic stem cell - derived compound — called GRNOPC1 — to treat spinal cord injury.

The National Institute of Neurological Disorders and Stroke (NINDS) has selected SMA to serve as the prototype for a translational research project that is expected to yield drug candidates for investigational new drug application filings by 2007.

Cambridge, MA — February 6, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company's lead program, light - activated AU - 011 in ocular melanoma (OM).

The team is conducting additional research toward an investigational new drug application from the federal Food and Drug Admission.

Raman says the next big steps are in overcoming the technical challenges of delivering the drug, and completing the experiments essential to file for an Investigational New Drug Application with the Food and Drug Administration to start clinical trials.

April 23, 2018 Ultragenyx Announces Filing and FDA Clearance of an Investigational New Drug Application for DTX401, a Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia

San Diego, May 22, 2017 — ViaCyte, Inc., a privately - held leading regenerative medicine company, announced today that the U.S. Food and Drug Administration (FDA) has allowed the company's Investigational New Drug Application (IND) for the PEC - Direct ™ product candidate, a novel islet cell replacement therapy in development as a potential cure for patients with type 1 diabetes who are at high risk for acute life - threatening complications.

The $ 1 million grant will be used for preclinical trial work with the goal of submitting an Investigational New Drug application to the FDA to begin clinical trials.

According to Prothena, «An Investigational New Drug application, or IND, for PRX002 was filed and accepted by the FDA in March 2014.

ViaCyte announced the achievement of several business and product development milestones in the past three months, including the acceptance by the U.S. Food and Drug Administration of its Investigational New Drug application (IND) allowing the first evaluation of VC - 01 in human clinical trials.

The Investigational New Drug application for the Phase 1/2 trial, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was allowed by the US Food and Drug Administration in August 2014.

June 29, 2006 deCODE genetics (Nasdaq: DCGN) today announced that it has submitted an investigational new drug application (IND) to the US Food and Drug Administration (FDA) for DG051, the company's follow - on investigational compound for the prevention of heart...

Reykjavik, ICELAND, January 13, 2005 — deCODE genetics (Nasdaq: DCGN) has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for DG041, a novel, first - in - class, orally - administered small molecule for the treatment of...

Investigational New Drug Application (IND)-- a key step in development of a new drug or medical treatment in which the US Food and Drug Administration (FDA) is notified that a novel therapeutic will be used experimentally