About the company
Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases.
The company has a strong and growing portfolio of commercial and development assets.
How it is doing 02 Jun 2021
Amryt Pharma PLC s (NASDAQ:AMYT, LON:AMYT) new drug application for its potential treatment for epidermolysis bullosa (EB) has been approved by the US regulator.
The Food and Drug Administration (FDA) accepted Amrty’s application for Oleogel-S10 to be approved as a treatment for cutaneous manifestations of junctional and dystrophic EB, which affects adults and young children and for which there is no currently approved treatment.
/PRNewswire/ Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and Bausch + Lomb, its leading global eye health business, along with Clearside.
The US Food and Drug Administration will raise any potential issues before 12 June
Amryt Pharma PLC s (NASDAQ:AMYT, LON:AMYT) new drug application for its potential treatment for epidermolysis bullosa (EB) has been approved by the US regulator.
The Food and Drug Administration (FDA) accepted Amrty’s application for Oleogel-S10 to be approved as a treatment for cutaneous manifestations of junctional and dystrophic EB, which affects adults and young children and for which there is no currently approved treatment.
Any potential filing review issues, including priority review determination and the Prescription Drug User Fee Act target action date for the application will be provided by June 12, the FDA said.
Calliditas is developing Nefecon, a down regulator of IgA1 and proprietary, novel oral formulation of budesonide – a potent and established immunosuppressant – for the treatment of IgAN.