regulatory

News

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

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The FDA has steadied the ship at CDER by naming veteran regulator Richard Pazdur as director, although he was reportedly reluctant to take the job.

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The battle for obesity drug developer Metsera rumbles on, with Pfizer reported to have now matched Novo Nordisk's $10 billion offer.

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Biohaven's troriluzole candidate for spinocerebellar ataxia (SCA) has been turned down by the FDA, in another sign of a tougher stance by the agency.