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US vulnerable to China's API dominance, says report

China has such a dominant position in pharmaceutical ingredient production that there is a risk it will weaponise access, says a Congressional report.

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Sarepta rises after FDA adds warning label to Elevidys

Uncertainty ends Sarepta's Duchenne gene therapy Elevidys ends after an FDA label update, with the company's shares on the up despite restrictions.

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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.

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FDA appoints veteran Pazdur to replace Tidmarsh

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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GLP-1s feature in second batch of national priority vouchers

GLP-1 drugs for weight loss, cancer, and rare diseases feature among the latest crop of medicines awarded priority vouchers by the FDA.

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Company representatives with President Trump in the Oval Office

Novo, Lilly sign MFN pricing deal with Trump administration

The pricing agreement between Novo Nordisk and Eli Lilly and the Trump administration on GLP-1 drugs for diabetes and obesity has arrived.

US vulnerable to China's API dominance, says report

Sarepta rises after FDA adds warning label to Elevidys

FDA unveils swift route to market for personalised drugs

FDA appoints veteran Pazdur to replace Tidmarsh

GLP-1s feature in second batch of national priority vouchers

Novo, Lilly sign MFN pricing deal with Trump administration

Tenpoint eyes presbyopia drug launch after FDA nod

How to meet your physicians where they are online

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