An FDA advisory committee has given tentative backing to Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD), even though the agency’s reviewers said they were no
ADC Therapeutics has said it will not seek accelerated approval of its Hodgkin lymphoma drug camidanlumab tesirine (cami) based on phase 2 results, as the FDA will not review it unless a co
Sarepta Therapeutics has followed through on its promise to file for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), as it aims for a launch in the
Cerevel Therapeutics’ Parkinson’s disease therapy tavapadon has shown efficacy in a phase 3 trial, reinforcing its blockbuster potential and no doubt delighting AbbVie whi
It’s 2024, and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another.