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STAT+: Axsome wins FDA nod for Alzheimer’s agitation

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The FDA named Katherine Szarama acting head of CBER as it continues to search for a permanent leader. Julia Vitarello is launching a new effort to scale bespoke medicines after her first startup faltered.

And Matt Herper reflects on the legacy of genomics pioneer J. Craig Venter, whose vision helped shape modern biotech.

Continue to STAT+ to read the full story…

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Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

The FDA named Katherine Szarama acting head of CBER as it continues to search for a permanent leader. Julia Vitarello is launching a new effort to scale bespoke medicines after her first startup faltered.

And Matt Herper reflects on the legacy of genomics pioneer J. Craig Venter, whose vision helped shape modern biotech.

Continue to STAT+ to read the full story…

Read More

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Moderna in talks with FDA over Phase 4 Covid vaccine data

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Moderna said it’s working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use to a wider group after FDA leaders narrowed the label for the products last year.

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FDA approves Pfizer and Arvinas’ breast cancer drug despite underwhelming data

FDA approves Pfizer and Arvinas’ breast cancer drug despite underwhelming data

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The FDA on Friday approved Pfizer and Arvinas’ drug vepdegestrant for patients with a certain form of breast cancer. But it’s unclear how many will take it.

The drug will be …​ ​Read More

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Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research

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Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell.

With a team largely made up of Karuna Therapeutics veterans, Seaport is looking to push even further in …

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