This is the company's fourth product candidate to receive orphan drug designation from the FDA. Rett syndrome is a rare and severe genetic neurodevelopmental disorder affecting females almost
Tonix recently launched the Phase 3 HONOR study of Tonmya in military-related PTSD, from which topline results are expected to be reported in the second half of 2018.
PRX002/RG7935 is an anti-alpha-synuclein antibody under investigation as a disease-modifying treatment for Parkinson's disease and is the focus of a worldwide collaboration between Prothena and Roche. The start
Top-line results from the HEALOS trial are expected in the fall of 2017. "We are very pleased that our first Phase 3 clinical trial of AM-111 is now
The funding agreement was announced today in a positive final evaluation determination (FED) issued by the NICE Highly Specialised Technologies (HST) Evaluation Committee to recommend Strensiq according to
Dasiglucagon is a potential first-in-class glucagon analog invented and developed by Zealand. It has a unique stability profile in liquid formulation and is suitable for a ready-to-use rescue
Following receipt of the BLA, the FDA conducts an initial assessment of the application to determine its fileability. The FDA typically notifies the applicant of their filing decision
The Olumiant approval is based on the results of the baricitinib development program, which includes four phase 3 clinical trials enrolling various populations of more than 3,000 moderate-to-severe
“We are excited to be bringing Triptodur, a new treatment option for children impacted by the disruptive effects of CPP, to the U.S. market,” said Ed Schutter, President
This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor ALL. Adults with Ph+ relapsed
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