regulatory

News

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

The FDA has rounded out its senior leadership by naming biopharma industry executive George Tidmarsh to the role of CDER director.

News

Sarepta has defied an FDA request to halt all use of its gene therapy for Duchenne muscular dystrophy, creating an intriguing regulatory impasse.

News

FDA advisors have voted that the benefit/risk profile of GSK's multiple myeloma therapy, Blenrep, does not support its approval in the US.

News

Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy, a major cause of blindness.

News

The WHO has recommended Gilead's twice-yearly HIV PrEP drug lenacapavir, calling it 'transformational', but there are concerns about patient access.