regulatory

News

The FDA has sent a warning letter to ImmunityBio over "false and misleading" comments made by executive chair, billionaire Patrick Soon-Shiong.

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FDA seeks public input on controversial priority voucher scheme amid concerns about its transparency and legality.

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New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.

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The aligned regulatory pathway for UK drugs regulator MHRA and reimbursement authority NICE gets underway on 1st April.

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Novo Nordisk has been sent a warning letter from the FDA for violations of postmarketing adverse drug experience (PADE) regulations.

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The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.