News Vinay Prasad abruptly departs from the FDA The disruption at the FDA continues with the departure of CBER director Vinay Prasad, less than three months after taking on the role.
News FDA gives the go-ahead to restart Elevidys shipments Sarepta has restarted distribution of its Duchenne muscular dystrophy gene therapy Elevidys, but only for patients who can walk.
News Lilly's appeal unlocks EU approval of Alzheimer's drug Eli Lilly's appeal of a decision by the EMA's human medicines committee not to approve its Alzheimer's disease therapy Kisunla has paid off.
News Sarepta backs down and pauses Elevidys shipments The FDA seems to have won its staring contest with Sarepta over shipments of Elevidys, as the company blinks and agrees to a pause from today.
News FDA names a new CDER director, choosing a biotech vet The FDA has rounded out its senior leadership by naming biopharma industry executive George Tidmarsh to the role of CDER director.
News Sarepta resists as FDA seeks pause on Elevidys use Sarepta has defied an FDA request to halt all use of its gene therapy for Duchenne muscular dystrophy, creating an intriguing regulatory impasse.
R&D The long-delayed promise of the microbiome, with Sam Possemi... Sam Possemiers, CEO of MRM Health, believes that the microbiome space is finally coming into maturity.
Sales & Marketing Sponsored How to meet your physicians where they are online A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.
