News

EMA accepts regulatory submission for olipudase alfa, the first potential therapy for ASMD

NPUK at 30 (NPUK News 2021)

Orphazyme provides regulatory update following Type A meeting with FDA on arimoclomol in Niemann-Pick disease type C

Progress made in understanding potential resolution of topics outlined in Complete Response Letter, including need for additional data to support NDA. FDA recommends the company provides supplemental information and analyses, and the FDA offers to have further interactions to identify a path to resubmission for arimoclomol in NPC...

Orphazyme provides regulatory and financial updates

Cyclo Therapeutics Appoints Lise Lund Kjems, MD, PhD as Chief Medical Officer

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced the appointment of Lise Lund Kjems, MD, PhD as Chief Medical Officer...