regulatory

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Savara shares are pummelled after the FDA says it cannot accept a filing for lead drug Molbreevi, but it is still hopeful of an approval in 2026.

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The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity.

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There was good news for Johnson & Johnson at this week's ODAC meetings, but not for Roche, UroGen, and Pfizer.

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The FDA has introduced a stricter set of policies around COVID-19 vaccines, including requiring clinical trials for new shots in some cases.

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After losing ground in commercial clinical trials in recent years, the UK has now turned a corner and is once again taking a "global lead."

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The Trump administration wants the public to join in the effort to cull redundant health regulations as part of its '10-for-one' deregulation policy.