regulatory

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Tidmarsh to stand in for Prasad's role at CBER

Following Vinay Prasad's abrupt departure as CBER director, FDA has asked CDER head George Tidmarsh to take on both roles while a successor is sought.

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AbbVie files to move Venclexta combo into the CLL front line

AbbVie has filed for FDA approval of a new front-line therapy for chronic lymphocytic leukaemia that it thinks could be 'practice changing."

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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.

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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.

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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.

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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.

Tidmarsh to stand in for Prasad's role at CBER

AbbVie files to move Venclexta combo into the CLL front line

Vinay Prasad abruptly departs from the FDA

FDA gives the go-ahead to restart Elevidys shipments

Lilly's appeal unlocks EU approval of Alzheimer's drug

Sarepta backs down and pauses Elevidys shipments

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