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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

A woman holds her hands up in a signal of 'No'

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.

News

GSK's growth plans dented by Blenrep setback

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

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Blue model of employee slumped at desk with letter cubes spelling 'FIRED'

HHS layoffs are finalised as thousands of pink slips arrive

Federal staffers voice their anger and disgust as thousands of the Trump administration's reduction-in-force job losses are finalised.

News

Just how radical is the FDA's complete response letter move?

The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.

Sarepta backs down and pauses Elevidys shipments

FDA names a new CDER director, choosing a biotech vet

Sarepta resists as FDA seeks pause on Elevidys use

GSK's growth plans dented by Blenrep setback

HHS layoffs are finalised as thousands of pink slips arrive

Just how radical is the FDA's complete response letter move?

UK MHRA green lights AbbVie’s ELAHERE for ovarian cancer

The value of a partner, globally and locally

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