Almost against the odds, Sarepta’s gene therapy for muscle-wasting disease Duchenne muscular dystrophy (DMD) has been given accelerated approval by the FDA, albeit in a fa
Swiss biotech Santhera has found a North American partner for its Duchenne muscular dystrophy (DMD) therapy vamorolone, ahead of an FDA decision on the drug due by 26th Oc
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
Swiss biotech Santhera has raised CHF 22 million ($23.5 million) in bridge financing that it says will allow it to fund its operations through to October, when the FDA is
Motion capture technology used to bring fantasy characters to life in movies like Avatar and The Lord of the Rings is being used alongside artificial intelligence (AI) to track diseases tha
Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023.
Bavarian Nordic is preparing to file for regulatory approval of a vaccine against chikungunya virus after its CHIKV VLP candidate showed protective efficacy in a second ph
To improve trial recruitment, engagement, and retention, and to increase the likelihood that trials reflect what matters most to patients, regulatory authorities increasingly point to metho