Bluebird bio Inc said on Monday it has submitted a marketing application to the FDA for its gene therapy to treat sicklecelldisease.
- Bluebird bio Inc said on Monday it has submitted a marketing application to the U.S. Food and Drug Administration for its gene therapy to treat sickle cell disease.
The announcement comes nearly a month after the company said it would miss its goal to submit the application by the end of March for regulatory approval of lovo-cel, its gene therapy. Bluebird said on Monday its application to the health regulator included a request for priority review, which if granted would reduce the review period to six months from the standard ten months.
The company is seeking approval for use of its therapy as a treatment for patients aged 12 and older, who are suffering from sickle cell disease, and who have a history of painful complications associated with the disease. The gene therapy is being developed as a potential one-time treatment for the disorder, which leads to a shortage of healthy blood cells due to some of them being sickle shaped and restricting circulation in blood vessels.My Alerts
México Últimas Noticias, México Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
The Blue-Collar Ballads of Donovan WoodsCatch the singer-songwriter at the Bluebird on Thursday!
Leer más »
'High bio-hazard risk' in Sudan after laboratory seized, WHO saysThere is a 'high risk of biological hazard' in Sudan's capital Khartoum after one of the warring parties seized a laboratory holding measles and cholera pathogens and other hazardous materials, the World Health Organization said on Tuesday.
Leer más »
FDA grants accelerated approval to Biogen treatment for rare form of ALSThe FDA has deemed Biogen's torferson reasonably likely to produce a clinical benefit for patients.
Leer más »
Fourth-generation NYPD cop to graduate Monday, continuing family’s century of policingWhen the 25-year-old graduates from the New York City Police Academy on Monday, he’ll be the fourth generation of his family to tack on a patrolman’s shield and keep watch over the Big …
Leer más »
Early Voting in Municipal Elections Starts MondayPolls open tomorrow morning for early voting in local races across North Texas ahead of the May 6 election.
Leer más »
Northeast Ohio Monday weather forecast: Rain and snow showers in the morningSkies will clear later in the afternoon but it will remain chilly.
Leer más »