BioXcel Therapeutics Inc (NASDAQ: BTAI) plans to finalize study design, dosing, and endpoints for its BXCL501 Phase 3 program in dementia-related agitation. The end of the Phase 2 meeting with the FDA is scheduled in Q2 2021.
BXCL501 is an orally dissolving thin film formulation of. Read More.
Orphan Drug Designation Granted to Rezafungin in EU for the Treatment of Invasive Candidiasis sina.com.tw - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sina.com.tw Daily Mail and Mail on Sunday newspapers.
SAN DIEGO, Jan. 12, 2021 Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug
(ASX:ANP) says it has received notification that the European Commission has designated ATL1102 as an orphan medicinal product for Duchenne muscular dystrophy (DMD).
The company said orphan designation was granted by the European Commission based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products in November 2020.
This latest news follows the recent granting of both Orphan Drug Designation and Rare Pediatric Disease Designation for ATL1102 in DMD by the US FDA.
Orphan status in the EU brings development and marketing incentives, such as reduced fees on scientific advice and marketing authorisation application, and market exclusivity in Europe for ten years upon regulatory approval with an additional two years of exclusivity for its pediatric use in DMD.