FDA Panel Endorses Gene Therapy For A Form Of Childhood Blindness

After many setbacks for genetic therapies, advisers to the Food and Drug Administration recommended approval of the first gene tr.....»»

Category: topSource: nprOct 12th, 2017

Seeing hope: FDA panel considers gene therapy for blindness

Advisers to the U.S. Food and Drug Administration will meet Thursday to consider whether to recommend approval of a gene therapy aimed at improving vision for some people with hereditary blindness......»»

Category: topSource: foxnewsOct 9th, 2017

FDA Panel Votes to Support Leukemia Gene-Therapy Treatment

A group of cancer experts voted unanimously to support U.S. regulatory approval for a first-of-its kind gene therapy targeting an aggressive form of leukemia in children and young adults......»»

Category: smallbizSource: wsjJul 13th, 2017

The Latest: FDA panel endorses potential 1st US gene therapy

The Latest on a Food and Drug Administration panel's review of a gene therapy treatment (all times local): 3:30 p.m......»»

Category: topSource: foxnewsJul 12th, 2017

Spark: A Big Win for Gene Therapy. So Why Is It Falling?

Shares of Spark Therapeutics are down today, despite winning the recommendation of a FDA advisory panel for its experimental gene therapy......»»

Category: blogSource: barronsOct 13th, 2017

Spark Therapeutics shares jump 7.5% after FDA committee backs blindness treatment

Shares of Spark Therapeutics Inc. surged 7.5% premarket Friday, after a U.S. Food and Drugs Administration advisory committee recommended approval of the company's gene therapy treatment for a rare eye disease that causes blindness. .....»»

Category: topSource: marketwatchOct 13th, 2017

A first-of-its-kind treatment for blindness just got one step closer to approval

AP A US Food and Drug Administration (FDA) advisory committee just gave a critical recommendation for a cutting-edge gene therapy.  The treatment, called Luxturna, treats Leber congenital amaurosis,&nbs.....»»

Category: topSource: businessinsiderOct 12th, 2017

FDA advisory panel recommends approval of Spark Therapeutics" gene therapy

A Food and Drug Administration advisory committee voted Thursday to recommend approval of Spark Therapeutics’ application for its experimental gene therapy developed to treat vision loss caused by an inherited retinal disease. The company, which .....»»

Category: topSource: bizjournalsOct 12th, 2017

Gene Therapy: How a New Cure for Blindness Reverses Retinal Dystrophy

The one-time treatment could restore eyesight to thousands of people......»»

Category: topSource: newsweekOct 12th, 2017

A gene therapy that could cure blindness is on the brink of getting approved (ONCE)

APA girl saw her mother's face for the first time. A boy tore through the aisles of Target, marveling at toys he never knew existed. A teen walked onto a stage and watched the stunned expressions of celebrity judges as he wowed "America's.....»»

Category: topSource: businessinsiderOct 10th, 2017

FDA considers gene therapy for blindness

FDA advisers will mull whether to recommend approval of a gene therapy that improved vision. It would be the first gene therapy in the U.S. for an inherited disease. .....»»

Category: topSource: usatodayOct 9th, 2017

Spark Therapeutics applies to market investigational therapy in Europe

The gene therapy company that spun out of Children's Hospital of Philadelphia is moving forward with a regulatory review of its treatment of an inherited disease that leads to blindness in Europe – laying the groundwork for the investigational therapy .....»»

Category: topSource: bizjournalsJul 31st, 2017

FDA panel backs Novartis" pioneering new cancer gene therapy

(Reuters) - Novartis AG's pioneering new cancer drug won enthusiastic support from a federal advisory panel on Wednesday, paving the way for approval of the first U.S. gene therapy......»»

Category: topSource: reutersJul 12th, 2017

Why Spark"s CEO says 2017 may be a "historic year" for his gene therapy company

Philadelphia gene therapy company Spark Therapeutics said it is in the final stages of completing its rolling biologics license application for its lead product: a one-time treatment for an inherited retinal disease that causes blindness in children.....»»

Category: topSource: bizjournalsFeb 22nd, 2017

Cancer Treatment Update: Second Gene Therapy Receives Approval


Category: topSource: redinews18 hr. 50 min. ago

Cancer Treatment Update: Second Gene Therapy Receives Approval

The FDA approved Gilead's Yescarta for DLBCL, second CAR-T therapy in the United States. The reg.....»»

Category: worldSource: nytOct 20th, 2017

There Could Be 109% Upside In uniQure As Company Advances Gene Therapy Into Clinical Trials

Following its meeting with the FDA and the EMA, Uniqure NV (NASDAQ: QURE) announced it would expeditiously advance its adeno-associated virus, or AAV-based gene therapy, AMT-061 into pivotal trials in severe and moderately severe hemophilia B. .....»»

Category: blogSource: benzingaOct 20th, 2017

Gene Therapy: Latest CAR-T Therapy for Cancer Signals New Era for Life-Saving Treatments

But these breakthroughs are not going to come cheap......»»

Category: topSource: newsweekOct 20th, 2017

The FDA Just Approved a Second Revolutionary Gene Therapy. A Third Is Probably on the Way

The FDA approved Gilead's novel cancer-fighting gene therapy. The Food and Drug Administration (FDA) has approved Gilead Science unit Kite Pharma’s groundbreaking cancer gene therapy treatment Yescarta. I.....»»

Category: europeSource: fortuneOct 19th, 2017

A revolutionary treatment could help more than 10,000 people living with largely untreatable cancer (GILD)

AP/Elaine Thompson The FDA approved a second gene therapy to treat cancer, called Yescarta. The therapy works by taking a person's own cells, reprogramming them, and inserting them back into the body.....»»

Category: topSource: businessinsiderOct 19th, 2017

Fibrocell Science: A Very Appealing Gene Therapy Play

Fibrocell Science: A Very Appealing Gene Therapy Play.....»»

Category: topSource: seekingalphaOct 19th, 2017