31 January 2018 - Fast Track designation highlights high unmet medical need in the treatment of Fabry disease. ...
26 January 2018 - The economist behind the ‘priority review voucher,’ which advances treatments for neglected diseases. ...
23 January 2018 - Swedish Orphan Biovitrum announces that the FDA has issued a study may proceed letter for the ...
18 January 2018 - Aquestive Therapeutics today announced that the U.S. FDA has accepted for review the company’s new drug application ...
18 January 2018 - Cost of drug Emflaza, which came under scrutiny last year, will go up by 9% for regular ...
22 December 2017 - Regulatory review process proceeding in-line with company's expectations. ...
19 December 2017 - Luxturna is the first gene therapy approved in the U.S. to target a disease caused by mutations ...
18 December 2017 - The target comes as a surprise under a Republican administration that has shown little interest in addressing ...
14 December 2017 - Wilson Therapeutics today announced that the U.S. FDA has granted WTX101 fast track designation for the treatment ...
14 December 2017 - Amicus Therapeutics submitted a new drug application to the U.S. FDA to request approval of the ...
12 December 2017 - Patisiran could become the first in a new class of medicines known as RNAi therapeutics. ...
12 December 2017 - The U.S. FDA today expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic ...
30 November 2017 - ArmaGen today reported that the U.S. FDA has granted fast track designation to AGT-181, a novel, ...
20 November 2017 - PellePharm today announced that the U.S. FDA has granted both breakthrough therapy designation and orphan drug ...
16 November 2017 - Company plans to complete submission by year end. ...