regulatory

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Is FDA about to restrict vaccination even further?

Vinay Prasad, head of CBER, is reported to be planning to tighten regulations on vaccines after concluding that COVID-19 shots caused 10 child deaths.

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FDA starts priority review of BeOne's Venclexta rival

BeOne nears a possible FDA okay for sonrotoclax in mantle cell lymphoma, hoping to be the second BCL-2 inhibitor in the US after AbbVie's Venclexta.

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Novo Nordisk files Wegovy product that claimed rapid voucher

Novo Nordisk is using its recently awarded FDA priority voucher on a high-strength version of its obesity drug Wegovy.

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Innovent files high-dose mazdutide for obesity in China

Innovent has filed a new high-strength version of its weight-loss drug mazdutide in China, aiming to help people with severe obesity.

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Sanofi's type 1 diabetes drug poised for EU rollout

Sanofi is celebrating an approval recommendation in the EU for Teizeild, a first-in-class drug designed to delay the progression of type 1 diabetes.

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FDA unveils swift route to market for personalised drugs

FDA reveals a regulatory pathway for personalised therapies based on 'plausible mechanism', drawing on the bespoke gene-editing treatment of Baby KJ.

Is FDA about to restrict vaccination even further?

FDA starts priority review of BeOne's Venclexta rival

Novo Nordisk files Wegovy product that claimed rapid voucher

Innovent files high-dose mazdutide for obesity in China

Sanofi's type 1 diabetes drug poised for EU rollout

FDA unveils swift route to market for personalised drugs

Repligen builds in cell therapy with $1.5bn BioLife takeover

Discover a new era of healthcare panel engagement: Grounded ...

regulatory

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